CDER Drug and Biologic Approvals for Calendar Year 2007
Updated through June 30, 2007

New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date N022013 Olux-E clobetasol propionate Connetics 5 S 12-Jan-2007 N022000 Lialda mesalamine Shire 3 S 16-Jan-2007 N021234 Flector diclofenac epolamine INST Biochem 2 S 31-Jan-2007 N021777 Amrix cyclobenzaprine hydrochloride ECR Pharms 3 S 01-Feb-2007 N021887 Alli Orlistat GlaxoSmithKline 8 S 07-Feb-2007 N021977 Vyvanse lisdexamfetamine dimesylate New River 1 S 23-Feb-2007 N022021 Altace ramipril Cobalt 3 S 27-Feb-2007 N021985 Tekturna aliskiren Novartis 1 S 05-Mar-2007 N022059 Tykerb lapatinib GlaxoSmithKline 1 P 13-Mar-2007 N022044 Janumet sitagliptin/metformin hydrochloride Merck 4 S 30-Mar-2007 N022055 Altabax retapamulin GlaxoSmithKline 1 S 12-Apr-2007 N021817 Reclast zoledronic acid Novartis 3 P 16-Apr-2007 N021905 Valtropin somatropin Parexel 5 S 19-Apr-2007 N021412 Zolpidem Tartrate zolpidem tartrate Biovail 3 S 25-Apr-2007* N022051 Veramyst fluticasone furoate GlaxoSmithKline 2 S 27-Apr-2007 N050810 Azasite azithromycin InSite Vision 3 S 27-Apr-2007 N022058 Supprelin LA histrelin acetate Indevus 5 S 03-May-2007 N021829 Neupro rotigotine Schwarz BioSciences 1 S 09-May-2007 N022007 Perforomist formoterol fumarate dehydrate Dey 3 S 11-May-2007* N022047 Seroquel XR quetiapine fumarate AstraZeneca 3 S 17-May-2007 N022076 Locoid hydrocortisone butyrate Ferndale 3 S 18-May-2007 N021864 Lybrel levonorgestrel and ethinyl estradiol Wyeth 5 S 22-May-2007 N022064 Xyzal levocertirizine dihydrochloride UCB 5 S 25-May-2007 N022088 Torisel temsirolimus Wyeth 1 P 30-May-2007 N022052 Zyflo CR zileuton Critical Therapeutics 3 S 30-May-2007 N022038 Divigel estradiol Upsher-Smith 5 S 04-Jun-2007 N021738 Extina ketoconazole Stiefel Labs 3 S 12-Jun-2007 N022116 Lexiva fosamprenavir calcium GlaxoSmithKline 3 P 14-Jun-2007 N021875 Nuvigil armodafinil Cephalon 5 S 15-Jun-2007 N022081 Letairis ambrisentan Gilead Sciences 1 P 15-Jun-2007 N021753 Differin adapalene Galderma Labs 3 S 19-Jun-2007 N021990 Exforge amlodipine;valsartan Novartis 4 S 20-Jun-2007* N022057 Endometrin progesterone Ferring 3 S 21-Jun-2007 * N021412 Zolpidem Tartrate was tentatively approved on 09/21/2006 * N022007 Perforomist was tentatively approved on 04/27/2007 * N021990 Exforge was tentatively approved on 12/21/2006. New Drug Application (NDA) Tentative Approvals NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date N022032 Omeprazole Omeprazole Lachman Consultant Services 5 S 14-Jun-2007 * N022032 Omeprazole was tentatively approved on 06/14/2007 New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR): NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date N021974 lamivudine;stavudine lamivudine;stavudine Cipla Limited 4 P 19-Jan-2007 N021971 lamivudine;zidovudine; nevirapine lamivudine;zidovudine;nevirapine Cipla Limited 4 P 31-Jan-2007 N021988 lamivudine;zidovudine; nevirapine lamivudine;zidovudine;nevirapine Strides Arcolab Limited 4 P 02-Mar-2007 N021838 stavudine;lamivudine stavudine;lamivudine Strides Arcolab Limited 4 P 13-Mar-2007 N021854 stavudine;lamivudine; nevirapine stavudine;lamivudine;nevirapine Strides Arcolab Limited 4 P 13-Mar-2007 N022096 lamivudine;zidovudine; efavirenze lamivudine;zidovudine;efavirenze Strides Arcolab Limited 4 P 01-Jun-2007 N022097 lamivudine;stavidine; efavirenze lamivudine;stavidine;efavirenze Strides Arcolab Limited 4 P 01-Jun-2007 N021974 lamivudine 150mg/stavudine 30mg and  lamivudine 150mg/stavudine 40mg Tablets was tentatively approved on 01/19/2007 under PEPFAR. N021971 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/31/2007 under PEPFAR. N021988 lamivudine 300mg/zidovudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/02/2007 under PEPFAR. N021838 stavudine 40mg/lamivudine 150mg Tablets was tentatively approved on 03/13/2007 under PEPFAR. N021854 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/13/2007 under PEPFAR. N022096 lamivudine 150mg/zidovudine 300mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR. N022097 lamivudine 150mg/stavidine 40mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR. Biologic License Application (BLA) Approvals: BLA Number Proprietary Name Proper Name Applicant Review Classification Approval Date BL125166 Soliris eculizumab Alexion P 16-Mar-2007

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New dosage form
4 -   New combination
5 -   New formulation or new manufacturer
7 -   Drug already marketed, but without an approved NDA
8 -  OTC switch

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

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Last updated: July 12, 2007