FDA DRUG AND DEVICE PRODUCT APPROVALS

Volume 19 Number (8) August 1996Center for Drug Evaluation	Center for Devices andand Research	Radiological Health*George R. Scott (301) 443-3910	Julie Stuart (301) 594-2186Center for Biologics	Center for Veterinary MedicineEvaluation and ResearchNorman Turner (301) 827-3503Roger Eastep 	(301) 594-1623*To whom general inquiries should be directed.This report is compiled by the Division of Drug Information Resources, OM, CDER.It is available by subscription from the National Technical Information Service,Springfield, VA  22161.U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE                                                                                                                                                                                                      

NDA NUMBER          TRADE NAME             APPLICANT              ACTIVE INGREDIENT(S)APPROVAL DATE       (DOSAGE FORM)                                 STRENGTH(S)(CLASSIFICATION)                                                  CLASSIFICATION(S)               

***ORIGINAL AND SUPPLEMENTAL NDAs***	                           FOR NEW DRUG PRODUCTS 19-640             HUMATROPE               LILLY                   SOMATROPIN, BIOSYNTHETIC01-AUG-96          (INJECTABLE)            INDIANAPOLIS, IN        5MG/VIAL(SUPPL-013)                                45285                   (NEW INDICATION --                                                                   TREATMENT OF ADULT-ONSET                                                                   OR CHILDHOOD-ONSET ADULT                                                                   GROWTH HORMONE DEFICIENCY)20-165             NICODERM CQ             ALZA                    NICOTINE02-AUG-96          (FILM,                  PALO ALTO, CA           7MG/24HR(SUPPL-011)        EXTENDED RELEASE)       94303                   14MG/24HR                                                                   21MG/24HR                                                                   (RX TO OTC SWITCH)                                                                       (OTC)20-450             CEREBYX                 PARKE DAVIS             FOSPHENYTOIN SODIUM05-AUG-96          (INJECTABLE)            ANN ARBOR, MI           EQ 50MG PHENYTOIN SODIUM/ML(1 S)                                      48106                   (ANTICONVULSANT) 20-248             INTRALIPID 20%          PHARMACIA AND UPJOHN    SOYBEAN OIL07-AUG-96          (INJECTABLE)            KALAMAZOO, MI           20%(3 S)                                      49001                   (CALORIC SUPPLEMENT)     20-559             TRITEC                  GLAXO WELLCOME          RANITIDINE BISMUTH CITRATE08-AUG-96          (TABLET)                RES TRIANGLE PK, NC     400MG(2,4 S)                                    27709                   (HISTAMINE H-2 RECEPTOR                                                                   ANTAGONIST/CYTOPROTECTANT)                                                                   [TREATMENT OF PATIENTS                                                                    WITH                                                                   AN ACTIVE DUODENAL ULCER                                                                   ASSOCIATED WITH                                                                   HELICOBACTER PYLORI                                                                   INFECTION (IN COMBINATION                                                                   WITH CLARITHROMYCIN)]20-640             TAVIST-D                SANDOZ PHARMS           CLEMASTINE FUMARATE09-AUG-96          (TABLET,                EAST HANOVER, NJ        1.34MG(3 S)              EXTENDED RELEASE)       07936                   PHENYLPROPANOLAMINE                                                                   HYDROCHLORIDE                                                                   75MG                                                                   (ANTIHISTAMINE/                                                                   DECONGESTANT)                                                                       (OTC)20-273             DOVONEX                 WESTWOOD SQUIBB         CALCIPOTRIENE15-AUG-96          (OINTMENT)              BUFFALO, NY             0.005%(SUPPL-001)                                14213                   (NEW DOSAGE REGIMEN --                                                                   USE FOR UP TO ONE                                                                   YEAR FOR THE TREATMENT                                                                   OF MODERATE PLAQUE                                                                   PSORIASIS)20-503             PROVENTIL-HFA           3M                      ALBUTEROL SULFATE15-AUG-96          (AEROSOL, METERED)      SAINT PAUL, MN          EQ 0.09MG BASE/INH(3 S)                                      55144                   (BETA-2 AGONIST)                                                                   [TREATMENT OR PREVENTION                                                                   OF BRONCHOSPASM IN                                                                    PATIENTS 12 YEARS OF                                                                   AGE AND OLDER WITH                                                                   REVERSIBLE OBSTRUCTIVE                                                                   AIRWAY DISEASE]20-627             LEVONORGESTREL          WYETH AYERST            LEVONORGESTREL15-AUG-96          (IMPLANT)               PHILADELPHIA, PA        75MG/IMPLANT(3 S)                                      19101                   (PROGESTIN)                                                                   [PREVENTION OF PREGNANCY] 50-719             HELIDAC                 PROCTER AND GAMBLE      BISMUTH SUBSALICYLATE15-AUG-96          (TABLET, CHEWABLE;      CINCINNATI, OH          262.4MG/TABLET, CHEWABLE(4 S)              TABLET;                 45242                   METRONIDAZOLE                   CAPSULE)                                        250MG/TABLET                                                                   TETRACYCLINE HYDROCHLORIDE                                                                   500MG/CAPSULE                                                                   (ANTIULCER)                                                                   [USE IN COMBINATION WITH                                                                   AN H-2 ANTAGONIST FOR THE                                                                   TREATMENT OF PATIENTS                                                                    WITH AN ACTIVE DUODENAL                                                                   ULCER ASSOCIATED WITH                                                                   HELICOBACTER PYLORI                                                                   INFECTION]20-238             TAGAMET HB              SMITHKLINE BEECHAM      CIMETIDINE21-AUG-96          (TABLET)                PARSIPPANY, NJ          200MG(SUPPL-001)                                07054                   (NEW STRENGTH)                                                                       (OTC)19-415             FERTINEX                SERONO                  UROFOLLITROPIN23-AUG-96          (INJECTABLE)            NORWELL, MA             75IU/AMP(SUPPL-009)                                02061                   150IU/AMP                                                                   (NEW ROUTE                                                                   OF ADMINISTRATION --                                                                   SUBCUTANEOUS)20-470             CLARITIN-D 24 HOUR      SCHERING                LORATADINE23-AUG-96          (TABLET,                KENILWORTH, NJ          10MG(3 S)              EXTENDED RELEASE)       07033                   PSEUDOEPHEDRINE SULFATE                                                                   240MG                                                                   (ANTIHISTAMINE/                                                                   DECONGESTANT)                                                                   [RELIEF OF SYMPTOMS OF                                                                   SEASONAL ALLERGIC                                                                    RHINITIS]20-604             SEROSTIM                SERONO                  SOMATROPIN, BIOSYNTHETIC23-AUG-96          (INJECTABLE)            NORWELL, MA             5MG/VIAL(5 P, AA*, V**)                            02061                   6MG/VIAL                                                                   (HUMAN GROWTH HORMONE)                                                                    [TREATMENT OF AIDS WASTING                                                                   AND CACHEXIA]20-532             IVY BLOCK               ENVIRODERM              BENTOQUATAM26-AUG-96          (LOTION)                LOUISVILLE, KY          5%(1 P)                                      40203                   (PROTECTANT)                                                                   [PROTECTS AGAINST                                                                   POISON IVY, POISON OAK,                                                                   AND POISON SUMAC WHEN                                                                   APPLIED BEFORE CONTACT]                                                                       (OTC) 20-508             LAC-HYDRIN              BRISTOL MYERS           AMMONIUM LACTATE29-AUG-96          (CREAM)                 BUFFALO, NY             EQ 12% BASE(3 S)                                      14213                   (HUMECTANT)                                                                   [TREATMENT OF ICHTHYOSIS                                                                   VULGARIS AND XEROSIS]20-416             FERIDEX I.V.            ADV MAGNETICS           FERUMOXIDES30-AUG-96          (INJECTABLE)            CAMBRIDGE, MA           EQ 11.2MG IRON/ML(1 S)                                      02138                   (MRI CONTRAST MEDIUM)                                                                   [AN ADJUNCT TO MRI                                                                    (IN ADULT PATIENTS)                                                                   TO ENHANCE T2 WEIGHTED                                                                   IMAGES USED IN THE                                                                   DETECTION AND EVALUATION                                                                   OF LESIONS OF THE LIVER                                                                   THAT ARE ASSOCIATED WITH                                                                   AN ALTERATION IN THE                                                                   RETICULOENDOTHELIAL                                                                   SYSTEM (RES)]AA* - Priority Classification AIDS DrugV** - Designated Orphan Drug                          ***APPROVABLE ORIGINAL NDAs***An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter.  Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved.  Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved.20-619             BETOPTICPILO            ALCON                   BETAXOLOL HYDROCHLORIDE01-AUG-96          (SUSPENSION)            FORT WORTH, TX          0.25%                                           76134                   PILOCARPINE HYDROCHORIDE                                                                   1.75%                                                                   (ADRENOCEPTOR ANTAGONIST/                                                                   CHOLINERGIC AGONIST)20-587             SCLEROSOL               BRYAN                   TALC09-AUG-96          (AEROSOL, POWDER)       WOBURN, MA              4GM                                           01801                   (MINERAL)20-592             ZYPREXA                 LILLY                   OLANZAPINE30-AUG-96          (TABLET)                INDIANAPOLIS, IN        2.5MG                                           46285                   5MG                                                                   7.5MG                                                                   10MG                                                                   (ANTIPSYCHOTIC)                         ***ORIGINAL ABBREVIATED NDAs***74-072             ALBUTEROL               MEDISOL                 ALBUTEROL01-AUG-96          (AEROSOL, METERED)      EAST HANOVER, NJ        0.09MG/INH                                           07936                   (BETA-2 AGONIST)74-147             METOCLOPRAMIDE HCL      SANOFI WINTHROP         METOCLOPRAMIDE 02-AUG-96          (INJECTABLE)            NEW YORK, NY            HYDROCHLORIDE                                           10016                   EQ 5MG BASE/ML                                                                   (UPPER GI TRACT                                                                    MOTILITY STIMULATOR)74-537             SELEGILINE HCL          NOVOPHARM               SELEGILINE HYDROCHLORIDE02-AUG-96          (TABLET)                SCARBOROUGH, ONTARIO    5MG                                           CANADA                  (ANTIDYSKINETIC)74-565             SELEGILINE HCL          ENDO LABS               SELEGILINE HYDROCHLORIDE02-AUG-96          (TABLET)                GARDEN CITY, NY         5MG                                           11530                   (ANTIDYSKINETIC)74-641*            SELEGILINE HCL          LEDERLE                 SELEGILINE HYDROCHLORIDE02-AUG-96          (TABLET)                PEARL RIVER, NY         5MG                                           10965                   (ANTIDYSKINETIC)40-137             CHLORZOXAZONE           CHELSEA LABS            CHLORZOXAZONE09-AUG-96          (TABLET)                CINCINNATI, OH          500MG                                           45215                   (SKELETAL MUSCLE RELAXANT)40-159             MEDROXYPROGESTERONE     BARR                    MEDROXYPROGESTERONE ACETATE09-AUG-96          ACETATE                 POMONA, NY              2.5MG                   (TABLET)                10970                   5MG                                                                   10MG                                                                   (PROGESTIN)74-582*            DANAZOL                 BARR                    DANAZOL09-AUG-96          (CAPSULE)               POMONA, NY              200MG                                           10970                   (ANTERIOR PITUITARY                                                                   SUPPRESSANT)72-273             ALBUTEROL               ARMSTRONG PHARMS        ALBUTEROL14-AUG-96          (AEROSOL, METERED)      WEST ROXBURY, MA        0.09MG/INH                                           02132                   (BETA-2 AGONIST)74-390             DICLOFENAC SODIUM       NOVOPHARM               DICLOFENAC SODIUM15-AUG-96          (TABLET,                SCARBOROUGH, ONTARIO    75MG                   DELAYED RELEASE)        CANADA                  (NONSTEROIDAL                                                                    ANTI-INFLAMMATORY)* - First Time Product Available Generically74-557             LOCHOLEST               EON LABS                CHOLESTYRAMINE15-AUG-96          (POWDER)                LAURELTON, NY           EQ 4GM RESIN/SCOOPFUL                                           11413                   EQ 4GM RESIN/PACKET                                                                   (ANTIHYPERLIPIDEMIC)74-558             LOCHOLEST LIGHT         EON LABS                CHOLESTYRAMINE15-AUG-96          (POWDER)                LAURELTON, NY           EQ 4GM RESIN/SCOOPFUL                                           11413                   EQ 4GM RESIN/PACKET                                                                   (ANTIHYPERLIPIDEMIC)74-561             LOCHOLEST               EON LABS                CHOLESTYRAMINE15-AUG-96          (POWDER)                LAURELTON, NY           EQ 4GM RESIN/SCOOPFUL                                           11413                   EQ 4GM RESIN/PACKET                                                                   (ANTIHYPERLIPIDEMIC)74-562             LOCHOLEST LIGHT         EON LABS                CHOLESTYRAMINE15-AUG-96          (POWDER)                LAURELTON, NY           EQ 4GM RESIN/SCOOPFUL                                           11413                   EQ 4GM RESIN/PACKET                                                                   (ANTIHYPERLIPIDEMIC)40-125             THIORIDAZINE HCL        HI TECH                 THIORIDAZINE HYDROCHLORIDE16-AUG-96          (CONCENTRATE)           AMITYVILLE, NY          30MG/ML                                           11701                   (ANTIPSYCHOTIC)40-126             THIORIDAZINE HCL        HI TECH                 THIORIDAZINE HYDROCHLORIDE16-AUG-96          (CONCENTRATE)           AMITYVILLE, NY          100MG/ML                                           11701                   (ANTIPSYCHOTIC)64-118             NYSTOP                  PADDOCK LABS            NYSTATIN16-AUG-96          (POWDER)                MINNEAPOLIS, MN         100,000 UNITS/GM                                           55427                   (ANTIFUNGAL)74-621+            MEGESTROL ACETATE       BARR                    MEGESTROL ACETATE16-AUG-96          (TABLET)                POMONA, NY              20MG                                           10970                   (PROGESTERONE DERIVATIVE) 74-584             BACLOFEN                ROSEMONT                BACLOFEN19-AUG-96          (TABLET)                DENVER, CO              10MG                                           80223                   20MG                                                                   (SKELETAL MUSCLE RELAXANT)  74-698             BACLOFEN                CHELSEA LABS            BACLOFEN20-AUG-96          (TABLET)                CINCINNATI, OH          10MG                                           45215                   20MG                                                                   (SKELETAL MUSCLE RELAXANT)+ - Supplemental Abbreviated NDA40-146             FLUPHENAZINE HCL        PHARM ASSOC             FLUPHENAZINE HYDROCHLORIDE21-AUG-96          (ELIXIR)                CONESTEE, SC            2.5MG/5ML                                           29636                   (ANTIPSYCHOTIC)40-102             METHAZOLAMIDE           INVAMED                 METHAZOLAMIDE28-AUG-96          (TABLET)                DAYTON, NJ              25MG                                           08810                   50MG                                                                   (CARBONIC ANHYDRASE                                                                   INHIBITOR)64-065             OTICAIR                 BAUSCH AND LOMB         HYDROCORTISONE28-AUG-96          (SUSPENSION/DROPS)      TAMPA, FL               1%                                           33637                   NEOMYCIN SULFATE                                                                   EQ 3.5MG BASE/ML                                                                   POLYMYXIN B SULFATE                                                                   10,000 UNITS/ML                                                                  (ANTIBIOTIC/CORTICOSTEROID)                                                                   20-512             CLINISOL 15%            CLINTEC NUTR            AMINO ACIDS30-AUG-96          SULFITE FREE            DEERFIELD, IL           15%                   IN PLASTIC CONTAINER    60015                   (NUTRIENT REPLENISHER)                   (INJECTABLE)40-168             HYDROCORTISONE          MORTON GROVE            ACETIC ACID, GLACIAL30-AUG-96          AND ACETIC ACID         MORTON GROVE, IL        2%                   (SOLUTION/DROPS)        60053                   HYDROCORTISONE                                                                   1%                                                                  (ASTRINGENT/CORTICOSTEROID)74-229             NADOLOL                 ZENITH GOLDLINE         NADOLOL30-AUG-96          (TABLET)                NORTHVALE, NJ           20MG                                           07647                   40MG                                                                   (BETA ADRENERGIC BLOCKER)74-349             CIMETIDINE              DANBURY PHARMA          CIMETIDINE30-AUG-96          (TABLET)                DANBURY, CT             200MG                                           06810                   300MG                                                                   400MG                                                                   (HISTAMINE H-2 RECEPTOR                                                                   ANTOGONIST)74-531             FLUPHENAZINE            BEDFORD LABS            FLUPHENAZINE DECANOATE30-AUG-96          DECANOATE               BEDFORD, OH             25MG/ML                   (INJECTABLE)            44146                   (ANTIPSYCHOTIC)74-546*            CLOZAPINE               CREIGHTON               CLOZAPINE30-AUG-96          (TABLET)                EAST HANOVER, NJ        25MG                                           07936                   100MG                                                                   (ANTIPSYCHOTIC)* - First Time Product Available Generically74-559             NITROGLYCERIN           MYLAN PHARM             NITROGLYCERIN30-AUG-96          (FILM,                  MORGANTOWN, WV          0.6MG/HR                   EXTENDED RELEASE)       26504                   (VASODILATOR)74-590             CAPTOPRIL               BAKER NORTON            CAPTOPRIL30-AUG-96          (TABLET)                MIAMI, FL               12.5MG                                           33137                   25MG                                                                   50MG                                                                    100MG                                                                   (ANGIOTENSIN CONVERTING                                                                   ENZYME INHIBITOR)74-607             NITROGLYCERIN           MYLAN PHARMS            NITROGLYCERIN30-AUG-96          (FILM,                  MORGANTOWN, WV          0.4MG/HR                   EXTENDED RELEASE)       26504                   (VASODILATOR)74-609             NITROGLYCERIN           MYLAN PHARMS            NITROGLYCERIN30-AUG-96          (FILM,                  MORGANTOWN, WV          0.2MG/HR                   EXTENDED RELEASE)       26504                   (VASODILATOR)     ***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS***A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act.  Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired.  Final approval is also contingent upon conditions and information available to FDA remaining acceptable.  When the application receives final approval, the product may be legally marketed.  The effective approval date will be listed in this publication and in the "Approved Drug Products with Therapeutic Equivalence Evaluations" list published by FDA.  Additional information on these applications will become available to the public when the applications receive final approval.74-635             NAPROXEN SODIUM         NOVOPHARM               NAPROXEN SODIUM20-AUG-96          (TABLET)                SCARBOROUGH, ONTARIO    220MG                                           CANADA                  (NONSTEROIDAL                                                                   ANTI-INFLAMMATORY)74-570             ACYCLOVIR               ROXANE LABS             ACYCLOVIR30-AUG-96          (CAPSULE)               COLUMBUS, OH            200MG                                           43216                   (ANTIVIRAL)                  ***LABELING SUPPLEMENTS TO ORIGINAL NDAs***08-678             ISONIAZID               EON MANUFACTURE LABS    ISONIAZID01-AUG-96          (TABLET)                LAURELTON, NY           100MG                                           11413                   300MG                                                                   (LABELING REVISION --                                                                   OVERDOSAGE)19-640             HUMATROPE               LILLY                   SOMATROPIN, BIOSYNTHETIC01-AUG-96          (INJECTABLE)            INDIANAPOLIS, IN        5MG/VIAL                                           45285                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)17-407             CATAPRES                BOEHRINGER INGELHEIM    CLONIDINE HYDROCHLORIDE02-AUG-96          (TABLET)                RIDGEFIELD, CT          0.1MG                                           06877                   0.2MG                                                                   0.3MG                                                                   (LABELING REVISION --                                                                   DESCRIPTION;                                                                   CLINICAL PHARMACOLOGY;                                                                   INDICATIONS AND USAGE;                                                                   CONTRAINDICATIONS;                                                                   WARNINGS; PRECAUTIONS;                                                                   ADVERSE REACTIONS;                                                                   OVERDOSAGE; DOSAGE                                                                   AND ADMINISTRATION)20-165             NICODERM CQ             ALZA                    NICOTINE02-AUG-96          (FILM,                  PALO ALTO, CA           7MG                   EXTENDED RELEASE)       94303                   14MG                                                                   21MG                                                                   (LABELING REVISION --                                                                   PATIENT LABELING)                                                                       (OTC)19-640             HUMATROPE               LILLY                   SOMATROPIN, BIOSYNTHETIC05-AUG-96          (INJECTABLE)            INDIANAPOLIS, IN        5MG/VIAL                                           45285                   (LABELING REVISION --                                                                   PRECAUTIONS;                                                                   INFORMATION FOR PATIENTS;                                                                   ADVERSE REACTIONS)19-949             DIFLUCAN                PFIZER CENTRAL RES      FLUCONAZOLE06-AUG-96          (TABLET)                GROTON, CT              50MG                                           06340                   100MG                                                                   150MG                                                                   200MG                                                                   (LABELING REVISION --                                                                   PRECAUTIONS;                                                                   ADVERSE REACTIONS)19-950             DIFLUCAN                PFIZER                  FLUCONAZOLE06-AUG-96          (INJECTABLE)            NEW YORK, NY            2MG/ML                                           10017                   (LABELING REVISION --                                                                   PRECAUTIONS;                                                                   ADVERSE REACTIONS)                   20-090             DIFLUCAN                PFIZER                  FLUCONAZOLE06-AUG-96          (POWDER                 NEW YORK, NY            50MG/5ML                   FOR RECONSTITUTION)     10017                   200MG/5ML                                                                   (LABELING REVISION --                                                                   PRECAUTIONS;                                                                   ADVERSE REACTIONS)19-810             PRILOSEC                ASTRA MERCK             OMEPRAZOLE09-AUG-96          (CAPSULE,               WAYNE, PA               10MG                   DELAYED RELEASE         19087                   20MG                   PELLETS)                                        (LABELING REVISION --                                                                   ADVERSE REACTIONS;                                                                    OVERDOSAGE)19-847             CIPRO IV                BAYER                   CIPROFLOXACIN09-AUG-96          (INJECTABLE)            WEST HAVEN, CT          10MG/ML                                           06516                   (LABELING REVISION --                                                                   ADVERSE REACTIONS)19-857             CIPRO IV                BAYER                   CIPROFLOXACIN09-AUG-96          IN DEXTROSE 5%          WEST HAVEN, CT          200MG/100ML                   IN PLASTIC CONTAINER    06516                   (LABELING REVISION --                   (INJECTABLE)                                    ADVERSE REACTIONS)                   50-573             SANDIMMUNE              SANDOZ PHARM            CYCLOSPORINE09-AUG-96          (INJECTABLE)            EAST HANOVER, NJ        50MG/ML                                           07936                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)50-574             SANDIMMUNE              SANDOZ PHARM            CYCLOSPORINE09-AUG-96          (SOLUTION)              EAST HANOVER, NJ        100MG/ML                                           07936                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)50-625             SANDIMMUNE              SANDOZ PHARM            CYCLOSPORINE09-AUG-96          (CAPSULE)               EAST HANOVER, NJ        25MG                                           07936                   50MG                                                                   100MG                                                                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)20-474             VEXOL                   ALCON LABS              RIMEXOLONE14-AUG-96          (SUSPENSION/DROPS)      FOR WORTH, TX           1%                                           76134                   (LABELING REVISION --                                                                   DOSAGE AND ADMINISTRATION)50-143             CHLOROMYCETIN           PARKE DAVIS             CHLORAMPHENICOL14-AUG-96          (POWDER                 MORRIS PLAINS, NJ       25MG/VIAL                   FOR RECONSTITUTION)     07950                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)20-273             DOVONEX                 WESTWOOD SQUIBB         CALCIPOTRIENE15-AUG-96          (OINTMENT)              BUFFALO, NY             0.005%                                           14213                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)20-392             CYSTAGON                MYLAN                   CYSTEAMINE BITARTRATE16-AUG-96          (CAPSULE)               MORGANTOWN, WV          EQ 50MG BASE                                           26505                   EQ 150MG BASE                                                                   (LABELING REVISION --                                                                   DESCRIPTION; WARNINGS;                                                                   PRECAUTIONS;                                                                   ADVERSE REACTIONS;                                                                   OVERDOSAGE; HOW SUPPLIED)           50-578             FORTAZ                  GLAXO WELLCOME          CEFTAZIDIME20-AUG-96          (INJECTABLE)            RES TRIANGLE PK, NC     500MG/VIAL                                           27709                   1GM/VIAL                                                                   2GM/VIAL                                                                   6GM/VIAL                                                                   (LABELING REVISION --                                                                   ADVERSE REACTION)50-580             AZACTAM                 BRISTOL MYERS SQUIBB    AZTREONAM20-AUG-96          (INJECTABLE)            PRINCETON, NJ           500MG/VIAL                                           08543                   1GM/VIAL                                                                   2GM/VIAL                                                                   (LABELING REVISION --                                                                   CLINICAL PHARMACOLOGY;                                                                   CONTRAINDICATIONS;                                                                   WARNINGS;                                                                   ADVERSE REACTIONS)50-632             AZACTAM                 BRISTOL MYERS SQUIBB    AZTREONAM20-AUG-96          IN PLASTIC CONTAINER    PRINCETON, NJ           20MG/ML                   (INJECTABLE)            08543                   (LABELING REVISION --                                                                   CLINICAL PHARMACOLOGY;                                                                   CONTRAINDICATIONS;                                                                   WARNINGS;                                                                   ADVERSE REACTIONS)50-634             FORTAZ                  GLAXO WELLCOME          CEFTAZIDIME SODIUM20-AUG-96          IN PLASTIC CONTAINER    RES TRIANGLE PK, NC     EQ 10MG BASE/ML                   (INJECTABLE)            27709                   EQ 20MG BASE/ML                                                                   EQ 40MG BASE/ML                                                                   (LABELING REVISION --                                                                   ADVERSE REACTIONS)  50-646             CEPTAZ                  GLAXO WELLCOME          CEFTAZIDIME20-AUG-96          (INJECTABLE)            RES TRIANGLE PK, NC     (ARGININE FORMULATION)                                           27709                   500MG/VIAL                                                                   1GM/VIAL                                                                   2GM/VIAL                                                                   10GM/VIAL                                                                   (LABELING REVISION --                                                                   ADVERSE REACTIONS)   20-238             TAGAMET HB              SMITHKLINE BEECHAM      CIMETIDINE21-AUG-96          (TABLET)                PARSIPPANY, NJ          200MG                                           07054                   (LABELING REVISION --                                                                   PATIENT INFORMATION)                                                                       (OTC)19-415             FERTINEX                SERONO LABS             UROFOLLITROPIN23-AUG-96          (INJECTABLE)            NORWELL, MA             75IU/AMP                                           02061                   150IU/AMP                                                                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)19-264             PENTAM 300              FUJISAWA USA            PENTAMIDINE ISETHIONATE27-AUG-96          (INJECTABLE)            DEERFIELD, IL           300MG/VIAL                                           60015                   (LABELING REVISION --                                                                   DESCRIPTION;                                                                   CLINICAL PHARMACOLOGY;                                                                   CONTRAINDICATIONS;                                                                              WARNINGS; PRECAUTIONS;                                                                   ADVERSE REACTIONS;                                                                   DOSAGE AND ADMINISTRATION;                                                                   HOW SUPPLIED)19-779             IOPIDINE                ALCON LABS              APRACLONIDINE27-AUG-96          (SOLUTION/DROPS)        FORT WORTH, TX          HYDROCHLORIDE                                           76134                   1%                                                                   (LABELING REVISION --                                                                   CLINICAL PHARMACOLOGY;                                                                   WARNINGS; PRECAUTIONS)50-156             CHLOROMYCETIN           PARKE DAVIS             CHLORAMPHENICOL27-AUG-96          (OINTMENT)              MORRIS PLAINS, NJ       1%                                           07950                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)50-201             OPHTHOCORT              PARKE DAVIS             CHLORAMPHENICOL27-AUG-96          (OINTMENT)              MORRIS PLAINS, NJ       10MG/GM                                           07950                   HYDROCORTISONE ACETATE                                                                   5MG/GM                                                                   POLYMYXIN B SULFATE                                                                   100,000 UNITS/GM                                                                    (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)50-486             VIRA-A                  PARKE DAVIS             VIDARABINE27-AUG-96          (OINTMENT)              MORRIS PLAINS, NJ       3%                                           07950                   (LABELING REVISION --                                                                   SECTION(S) OF LABELING                                                                   REVISED NOT SPECIFIED                                                                   IN APPROVAL LETTER)15-923             HALDOL                  JOHNSON RW              HALOPERIDOL28-AUG-96          (INJECTABLE)            SPRING HOUSE, PA        EQ 5MG BASE/ML                                           19477                   (LABELING REVISION --                                                                   HOW SUPPLIED)20-180             PROSCAR                 MERCK RES LABS          FINASTERIDE28-AUG-96          (TABLET)                WESTPOINT, PA           5MG                                           19486                   (LABELING REVISION --                                                                   CLINICAL PHARMACOLOGY;                                                                   CONTRAINDICATIONS;                                                                   WARNINGS; PRECUATIONS;                                                                   HOW SUPPLIED;                                                                   PATIENT PACKAGE INSERT)19-651             ASACOL                  PROCTER GMBL PHARMS     MESALAMINE30-AUG-96          (TABLET,                NORWICH, NY             400MG                   DELAYED RELEASE)        13815                   (LABELING REVISION --                                                                   ADVERSE REACTIONS)                        ***BIOLOGICAL PRODUCT LICENSES ISSUED***0226             NONE                BLOOD BANKS OF            SOURCE PLASMA08-06-96         (INJECTABLE)        SAN BERNARDINO AND        (B)                                     RIVERSIDE CNTYS                                                SAN BERNARDINO, CA                                             924121207             CALYPTE HIV-1       CALYPTE BIOMED            HIV-TYPE 1 (RECOMBINANT)08-06-96         URINE EIA           BERKELY, CA               (KIT USED IN DETECTION OF                 (IN VITRO)                                    ANTIBODIES TO THE HIV                                                               PRESENT IN URINE)                                                               (A,B)1199             VERLUMA             DR KARL THOMAE GMBH       NOFETUMOMAB08-20-96         (NONE)              GERMANY                   (IMAGING AGENT FOR DETECTION                                                               OF EXTENSIVE STAGE DISEASE                                                               IN PATIENTS WITH BIOPSY-                                                                CONFIRMED, PREVIOUSLY                                                               UNTREATED, SMALL CELL                                                                LUNG CANCER)                                                               (A,B) 0991             NONE                AM-RHO LABS               SOURCE PLASMA08-22-96         (INJECTABLE)        CHARLESTON, GA            (B)                                     30021                     1202             NONE                CENTEON PHARMA GMBH       ANTIHEMOPHILIC FACTOR08-22-96         (INJECTABLE)        GERMANY                   (HUMAN)                                                               (FOR FURTHER MANUFACTURING                                                               USE)                                                               (A,B)(A) Establishment License Issued(B) Product License Issued                    ***BIOLOGICAL PRODUCT DEVICE APPROVALS***BK960054         JEWETT MODELS       JEWETT REFRIGERATOR       BLOOD STORAGE REFRIGERATORS08-08-96         BPL13, BPL21,       BUFFALO, NY               AND FREEZERS                 BPL25               14213                     (C)BK960002         ACT BUOYANT         ACTIVATED CELL THERAPY    SILANATED COLLODIAL SILICA08-12-96         DENSITY SOLUTION    MOUNTAIN VIEW, CA         SUPPLEMENTED WITH                                     94043                     POLYVINYNOLIDONE                                                               (C)BK950037         COMPONENTS AND      INFORMATION DATA MANGMNT  CDIS08-26-96         DISTRIBUTION        ROSEMONT, IL              (C)                 INFORMATION SYSTEM  60018BK950045         DONOR MANAGEMENT    INFORMATION DATA MANGMNT  DMIS08-26-96         INFORMATION SYSTEMS ROSEMONT, IL              (C)                 VERS. 1.2           60018(C) Substantially Equivalent              ***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL	HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION	RESOURCES PRIOR TO PUBLICATIONP940036      BARTELS              BARTELS PROGNOSTICS,    AN IN VITRO 08/01/96     CHEMORESPONSE        INC.                    DIAGNOSTIC DEVICE             ASSAY                ISSAQUAH, WA            INTENDED FOR USE TO                                       98027               DETERMINE RESISTANCE                                                          TO 5-FLUOROURACIL                                                            (5-FU) OF CELLS                                                               ISOLATED FROM BREAST                                                           TUMORS WHICH WILL                                                           ASSIST PHYSICIANS IN                                                          DETERMINING IF 5-FU                                                           IS AN INEFFECTIVE                                                          TREATMENT FOR                                                           RELAPSED BREAST                                                           CANCER PATIENTSP950034      SEPRAFILM           GENZYME CORP.            THE DEVICE IS   08/12/96     BIORESORBABLE       CAMBRIDGE, MA            INDICATED FOR USE             MEMBRANE                02139-1562           IN PATIENTS                                                            UNDERGOING ABDOMINAL                                                          OR PELVIC LAPAROTOMY                                                          AS AN ADJUNCT                                                                INTENDED TO REDUCE                                                           THE INCIDENCE, EXTENT,                                                          AND SEVERITY OF                                                           POSTOPERATIVE                                                          ADHESIONS BETWEEN                                                           THE ABDOMINAL WALL                                                           AND THE UNDERLYING                                                          VISCERA                 P960020      RELIANCE URINARY     UROMED CORP.            THE DEVICE IS   08/16/96     CONTROL INSERT       NEEDHAM, MA             INDICATED FOR THE             AND SIZING DEVICE        02194               MANAGEMENT OF STRESS                                                          URINARY INCONTINENCE                                                          IN ADULT WOMEN                  ***MEDICAL DEVICE - PMA SUPPLEMENTALS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL	HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION	RESOURCES PRIOR TO PUBLICATIONN50510/S069  VITEK GENERAL        BIOMERIEUX VITEK, INC.  REMOVAL OF 08/07/96     SUSCEPTIBILITY       HAZELWOOD, MO           LIMITATION FOR                CARD                     63042-2395          SUSCEPTIBILITY                                                          TESTING OF                                                          ENTEROCOCCI/                                                                   VANCOMYCIN TESTING                                                          ON THE DEVICE                                                                                P790018/S027 MEDTRONIC-HALL       MEDTRONIC, INC.         TRANSFER OF SEWING08/19/96     PROSTHETIC HEART     IRVINE, CA              RING FABRICATION AND             VALVE, MODELS            92714               ATTACHMENT, AND              A7700 AND M7700                              STERILE PACKAGING                                                          MANUFACTURING                                                           PROCESSES FROM THE                                                           MINNEAPOLIS,                                                           MN, FACILITY TO THE                                                          IRVINE, CA, FACILITY                                                        P830026/S067 COSMOS/NOVA/QUANT    INTERMEDICS, INC.       APPROVAL FOR THE USE08/19/96     UM/SUPRIMA/PULSE     ANGLETON, TX            OF AN ALTERNATE             GENERATORS               77515               CONDUCTIVE EPOXY AND                                                          A PRODUCTION PROCESS                                                          CHANGE FOR AUTOMATED                                                          APPLICATION OF THIS                                                          EPOXY IN THE                                                          MANUFACTURE OF                                                          IMPLANTABLE PULSE                                                          GENERATORSP830061/S026 MEDTRONIC            MEDTRONIC, INC.         ALTERNATE PACKAGING08/12/96     PACING LEADS         MINNEAPOLIS, MN         DESIGN                                      55432-3576 P830056/S077 POSTERIOR CHAMBER    MENTOR OPTHALMICS       APPROVAL FOR A 08/01/96     INTRAOCULAR          SANTA BARBARA, CA       MANUFACTURING SITE             LENSES                   93111               LOCATED AT CIDRA,                                                          PR 00639P830063/S001 GAMBRO AB            GAMBRO, INC.            CHANGE OF MATERIAL   08/28/96     PLASMAFILTER         LAKEWOOD, CO            USED IN THE HOUSING             PF 2000N AND             80215               OF THE DEVICE, END             EXCORIM KB MAXO                              CAP CONFIGURATION             PLASMAFILTER                                 MODIFICATION, AND                                                          SPECIFICATION CHANGES                                                          TO THE DEVICE                                                           MEMBRANE                                                             P840024/S066 NUCLEUS 22-          COCHLEAR, CORP.         APPROVAL FOR08/28/96     CHANNEL COCHLEAR     ENGLEWOOD, CO           IMPLEMENTING A NEW             IMPLANT SYSTEM           80112               DIAGNOSTIC AND                                                          PROGRAMMING SYSTEM                                                          SOFTWARE (DPS                                                           VERSION 6.125)                                                                               P850035/S020 EBI SPF              ELECTRO-BIOLOGY, INC.   THE DEVICE IS   08/20/96     IMPLANTABLE          PARSIPPANY, NJ          INDICATED FOR USE AS              SPINAL FUSION            07054-1079          A SPINAL FUSION              STIMULATOR MODEL                             ADJUNCT TO INCREASE               SPF-XL II                                    THE PROBABILITY OF                                                           FUSION SUCCESS IN 3                                                          OR MORE LEVELS                                                                            P850079/S028 HYDRASOFT,           COOPERVISION, INC.      APPROVAL FOR08/01/96     HYDRASOFT TORIC,     IRVINE, CA              REFORMATTING THE             HYDRASOFT XW AND         92718               PACKAGE INSERT,             HYDRASOFT TORIC XW                           PROFESSIONAL FITTING             (METHALICON B)                               AND INFORMATION             SOFT (HYDROPHILIC)                           GUIDE, AND PATIENT             CONTACT LENSES                               INSTRUCTIONS     P850089/S034 MEDTRONIC            MEDTRONIC, INC.         ALTERNATIVE PACKAGING08/12/96     PACING LEADS         MINNEAPOLIS, MN         DESIGN                                      55432-3576 P860007/S018 INTERTACH II         INTERMEDICS, INC.       APPROVAL FOR THE USE08/19/96     MODELS 262-16        ANGLETON, TX            OF AN ALTERNATE                                      77515               CONDUCTIVE EPOXY AND                                                          A PRODUCTION PROCESS                                                          CHANGE FOR AUTOMATED                                                          APPLICATION OF THIS                                                          EPOXY IN THE                                                          MANUFACTURE OF                                                           IMPLANTABLE PULSE                                                          GENERATORSP860019/S112 SCIMED RANGER        SCIMED LIFE SYSTEMS,    THE DEVICE IS   08/29/96     PERCUTANEOUS         INC.                    INDICATED FOR THE             TRANSLUMINAL         MAPLE GROVE, MN         BALLOON DILATATION             ANGIOPLASTY              55311-1566          OF THE STENOTIC             (PTCA) CATHETER                              PORTION OF A                                                                CORONARY ARTERY OR                                                          BYPASS GRAFT                                                           STENOSIS FOR THE                                                          PURPOSE OF IMPROVING                                                          MYOCARDIAL PERFUSIONP860019/S114 SCIMED NC BANDIT     SCIMED LIFE SYSTEMS,    MODIFICATION TO THE08/27/96     PERCUTANEOUS         INC.                    WRAP-IT ACCESSORY               TRANSLUMINAL         MAPLE GROVE, MN         TOOL             CORONARY                 55311-1566                           ANGIOPLASTY (PTCA)             CATHETERP870015/S022 MEDSTONE STS         MEDSTONE INTL., INC.    HARDWARE AND 08/19/96     LITHOTRIPTER         ALISO VIEJO, CA         SOFTWARE CHANGES                                      92656-4114          TO THE DEVICE       P870036/S039 MEDTRONIC            MEDTRONICS              NEW BALLOON SIZES08/30/96     FALCON CORONARY      INTERVENTIONAL          TO BE ADDED TO THE               BALLOON              SAN DIEGO, CA           FALCON 20 CORONARY              DILATATION               92121-2256          BALLOON DILATATION              CATHETERS                                    CATHETER LINE AND                                                           THE ADDITION OF THE                                                           FALCON 30 AND FALCON                                                          40 CORONARY BALLOON                                                          DILATATION CATHETER                                                          LINES ADDITIONALLY,                                                          SPECIFICATION AND                                                           QUALITY CONTROL                                                          INSPECTION CHANGES                                                           WERE REQUESTEDP880040/S003 CELLFREE             T CELL DIAGNOSTICS,     CHANGE IN ADDRESS OF 08/07/96     INTERLEUKIN-2        INC.                    THE MANUFACTURING              RECEPTOR BEAD        WOBURN, MA              SITE AND UPDATES AND             ASSAY KIT                01801               REVISIONS IN STANDARD                                                          OPERATING PROCEDURES                                                           AND MANUFACTURING                                                             INFORMATION                                                                         P890003/S045 MEDTRONIC VDD        MEDTRONIC, INC.         ALTERNATIVE PACKAGING08/12/96     STEROID-ELUTING      MINNEAPOLIS, MN         DESIGN             LEAD                     55432-3576P890023/S004 OCUFILCON D          OCULAR SCIENCES/        1)ADDITION OF AN IN-08/28/96     SPHERICAL AND        AMERICAN HYDRON         MONOMER TINT              TORIC EXTENDED       CUPERTINO, CA           INCORPORATING VAT              WEAR CONTACT             95014               BLUE 6 DYE DURING THE             LENSES                                       POLYMERIZATION PHASE                                                          OF THE MANUFACTURING                                                          PROCESS; 2) USE OF                                                          BLISTER PACKAGING AS                                                          ALTERNATE PACKAGING                                                          MATERIAL; AND 3)                                                          ALTERNATE                                                           MANUFACTURING SITEP890027/S035 NUCLEUS 22-          COCHLEAR, CORP.         APPROVAL FOR 08/28/96     CHANNEL COCHLEAR     ENGLEWOOD, CO           IMPLEMENTING A NEW             IMPLANT                  80112               DIAGNOSTIC AND                                                               PROGRAMMING SYSTEM                                                          SOFTWARE (DPS                                                           VERSION 6.125)                                                          P890064/S004 HYBRID               DIGENE DIAGNOSTICS,     CHANGES IN            08/28/96     CAPTURE HPV          INC.                    MANUFACTURING             DNA ASSAY            SILVER SPRING, MD       METHODS, PROCEDURES,                                      20904               AND LABELING                                                             MODIFICATIONS                                                                      P900023/S019 ABIOMED              ABIOMED, INC.           ELIMINATION OF THE   08/19/96     BVS 5000             DANVERS, MA             ISOLATOR VALVE             BI-VENTRICULAR           01923               ASSEMBLY FROM THE BVS             SUPPORT SYSTEM                               CONSOLEP900060/S011 CARBOMEDICS          CARBOMEDICS, INC.       APPROVAL FOR THE 21MM08/12/96     PROSTHETIC HEART     AUSTIN, TX              MITRAL CPHV, MODEL             VALVE (CPHV)             78752-1793          M700P900060/S013 CARBOMEDICS          CARBOMEDICS, INC.       APPROVAL FOR THE 08/27/96     PROSTHETIC HEART     AUSTIN, TX              USE OF AN ALTERNATE             VALVE (CPHV)             78752-1793          CONTROLLED              MODELS A500,                                 ENVIRONMENT FOR              R500, S500, M700,                            CPHV MANUFACTURING             MAND S700                                    OPERATIONSP900061/S028 MODEL                MEDTRONIC, INC.         APPROVAL FOR NEW08/06/96     7221/B/CX/D/E        MINNEAPOLIS, MN         MODEL AND THE MODEL                MICRO JEWEL              55432-3576          6836Y CONNECTOR             WITH ENDOTAK             SERIES LEADS                                              INCLUDING 60, 70                                          AND 110 SERIES                                            LEADS (MODELS 0060,                                       0062, 0063, 0064,             0070, 0072, 0073,             0074, 0075, 0113,             0115) AND THE MODEL             6836 Y CONNECTORP910020/S015 RELAY/DASH/STRIDE/   INTERMEDICS, INC.       APPROVAL FOR THE USE08/19/96     DART PACING          ANGLETON, TX            OF AN ALTERNATE             SYSTEMS                  77515               CONDUCTIVE EPOXY AND                                                          A PRODUCTION PROCESS                                                          CHANGE FOR AUTOMATED                                                          APPLICATION OF THIS                                                          EPOXY IN THE                                                          MANUFACTURE OF                                                          IMPLANTABLE PULSE                                                          GENERATORSP910031/S009 FACT BALLOON         CARDIOVASCULAR          APPROVAL FOR THE   08/20/96     CORONARY             DYNAMICS, INC.          22 MM MODELS OF THE               DILATATION           IRVINE, CA              FACT AND ARC BALLOON             CATHETER AND             92718               CORONARY DILATATION             ARC BALLOON                                  CATHETERS             CORONARY              DILATATION              CATHETERP920004/S001 VASOSEAL             DATASCOPE, CORP.        ADDITION OF A REDUCED08/01/96     VASCULAR             MONTVALE, NJ            TIME TO AMBULATION                HEMOSTASIS               07645               CLAIM TO THE                   DEVICE                                       INDICATIONS FOR USE                                                                            P920004/S002 VASOSEAL             COLLAGEN PRODUCTS       CHANGES TO THE 08/01/96     VASCULAR             DIVISION                INSTRUCTIONS FOR USE             HEMOSTASIS DEVICE    MONTVALE, NJ            TO ENHANCE THE                                       07645               SAFETY OF THE USE OF                                                          THE DEVICE                                                                    P920015/S010 MEDTRONIC SPRINT     MEDTRONIC, INC.         APPROVAL FOR THE08/06/96     MODEL 6932           MINNEAPOLIS, MN         MEDTRONIC SPRINT             LEAD                     55432-3576          MODEL 6932 LEADP930039/S001 MEDTRONIC            MEDTRONIC, INC.         ALTERNATIVE PACKAGING08/12/96     SCREW-IN STEROID     MINNEAPOLIS, MN         DESIGN             ELUTING LEAD             55432P940008/S002 RES-Q                INTERMEDICS, INC.       APPROVAL FOR A08/20/96     ARRHYTHMIA           ANGLETON, TX            SUPPLEMENT WHICH             CONTROL DEVICE           77515               SATISFIES THE             SYSTEMS                                      REQUIREMENT TO SUBMIT                                                          A POST-APPROVAL STUDY                                                          PROTOCOL FOR THE                                                          INTERMEDICS                                                          EPICARDIAL PATCH                                                          DEFIBRILLATION LEADSP940008/S003 RES-Q                INTERMEDICS, INC.       APPROVAL TO CONSIDER08/22/96     ARRHYTHMIA           ANGLETON, TX            THE INFORMATION             CONTROL DEVICE           77515               PROVIDED IN THIS             SYSTEMS                                      SUPPLEMENT AS AN                                                          ALTERNATIVE RESPONSE                                                          TO THE CONDITIONS OF                                                          APPROVAL SET FORTH IN                                                          THE FDA LETTER DATED                                                          NOVEMBER 7, 1995,                                                          WHICH REQUIRED THAT                                                          REMAINING MINOR                                                           SOFTWARE ANOMALIES                                                           BE CORRECTEDP940010/S001 OPTIGUIDE            QLT PHOTOTHERAPEUTICS,  CHANGE IN LABELING 08/07/96     FIBER OPTIC          INC.                    CONSISTING OF ADDING             DIFFUSER             VANCOUVER, B.C.,        AN ADDITIONAL WARNING             DCYL SERIES                                  STATEMENT CONCERNING                                                           POSSIBLE LEAKAGE OF                                                           BLOOD INTO DIFFUSER                                                          CAP                                                                               P940022/S001 CLARION              ADVANCED BIONICS,       MODIFY THE DESIGN OF08/02/96     MULTI-STRATEGY       CORP.                   THE CLARION MULTI-             COCHLEAR IMPLANT     SYLMAR, CA              STRATEGY COCHLEAR             VERSION 1.2 FOR          91342               IMPLANT FROM THE              ADULTS                                       ORIGINAL 1.0 VERSION                                                           TO THE MINIATURIZED                                                          1.2 VERSION                                                             P940034/S003 GEN-PROBE            GEN-PROBE, INC.         APPROVAL FOR CHANGING08/22/96     AMPLIFIED            SAN DIEGO, CA           THE PACKAGE INSERT             MYCOBACTERIUM            92121               FOR THE MTD KIT TO             TUBERCULOSIS                                 INCLUDE AN ADDITIONAL             DIRECT TEST (MTD                             WARNING AND AN             TEST)                                        EXPANDED LIMITATION                                                          REGARDING LOW                                                          POSITIVE RESULTS WITH                                                          MOTTP950039/S001 THINPREP             CYTYC, CORP.            RELOCATION OF CYTYC,08/22/96     PROCESSOR            BOXBOROUGH, MA          CORP., FROM              (MODEL TP 2000)          01719               MARLBOROUGH, MA TO                                                          BOXBOROUGH, MA                       ***ORIGINAL VETERINARY NADAs***141-063        NUFLOR INJECTABLE     CATTLE      SCHERING PLOUGH         FLORFENICOL31-MAY-96      SOLUTION                          AN HLTH                 300MG/ML               (SOLUTION)                        KENILWORTH, NJ                                                 07033                    ***ORIGINAL ABBREVIATED VETERINARY NADAs***THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR AUGUST 1996.                         ***SUPPLEMENTAL VETERINARY NADAs***140-897        REVALOR-G             CATTLE      ROUSSEL UCLAF           TRENBOLONE ACETATE02-JUL-96      (EAR IMPLANT)                     PARIS, FRANCE           20MG/PELLET                                                                         ESTRADIOL                                                                         4MG/PELLET140-915        INTERCEPTOR           DOGS        CIBA GEIGY AN HLTH      MILBEMYCIN OXIME09-JUL-96      FLAVOR TABS                       GREENSBORO, NC          2.3MG               (TABLET)                          27419                   5.7MG                                                                         11.5MG                                                                         23MG141-034        FLAVOMYCIN            CATTLE      HOECHST ROUSSEL         BAMBERMYCINS26-AUG-96      (TYPE A                           AGRI VET                10GM/LB               MEDICATED ARTICLE)                SOMERVILLE, NJ                                                 08876