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CDER Drug and Biologic Approvals for Calendar Year 2008
Updated through July 31, 2008

 

New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification 505(b)(2) Approval Date
N021658 Alvesco ciclesonide Nycomed 3 S Y 10-Jan-2008
N022067 Flo-Pred prednisolone acetate Taro 3 S Y 17-Jan-2008
N022107 Tekturna HCT aliskiren/hydrochlorothiazide Novartis 4 S   18-Jan-2008
N022187 Intelence etravirine Tibotec 1 P   18-Jan-2008
N021538 Accretropin somatropin Chesapeake 5 S Y 23-Jan-2008
N050813 Moxatag amoxicillin MiddleBrook 3 S Y 23-Jan-2008
N022023 Emend fosaprepitant dimeglumine Merck & Co 2 S Y 25-Jan-2008
N022157 Xyzal levocetirizine dihydrochloride UCB, Inc. 3 S   28-Jan-2008
N022078 Simcor niacin/simvastatin Abbott 4 S Y 15-Feb-2008
N022029 Salonpas methyl salicylate & menthol Hisamitsu 3,4 S Y 20-Feb-2008
N022028 Cosyntropin corticotropin Sandoz 5 S Y 21-Feb-2008
N022101 Nexium esomeprazole magnesium AstraZeneca 3 S   27-Feb-2008
N022033 Luvox CR fluvoxamine maleate Solvay 3 S Y 28-Feb-2008
N021992 Pristiq desvenlafaxine succinate Wyeth 1 S   29-Feb-2008
N020140 Isovorin levoleucovorin calcium Spectrum 5 S,O   07-Mar-2008
N022195 Morphine Sulfate morphine sulfate Roxane 7 S Y 17-Mar-2008
N022207 Morphine Sulfate morphine sulfate Roxane 7 S Y 17-Mar-2008
N022056 Prilosec omeprazole AstraZeneca 3 S   20-Mar-2008
N022249 Treanda bendamustine hydrochloride Cephalon 1 P,O Y 20-Mar-2008
N022009 Anthelios 40 avobenzone;ecamsule;octocrylene; titanium dioxide L'Oreal 3 S Y 31-Mar-2008
N022161 Lexiscan regadenoson CV Therapeutics 1 S   10-Apr-2008
N022235 Luvox fluvoxamine maleate Jazz 3 S Y 14-Apr-2008
N021861 Patanase olopatadine hydrochloride Alcon Research 3 S Y 15-Apr-2008
N021926 treximet sumatriptan;naproxen sodium Pozen 4 S Y 15-Apr-2008
N022108 Aplenzin bupropion hydrobromide Biovail Lab 2 S Y 23-Apr-2008
N021964 Relistor methylnaltrexone bromide Progenics 1 S   24-Apr-2008
N021795 Minirin desmopressin acetate Ferring 5 S Y 08-May-2008
N022159 OraVerse phentolamine mesylate Novalar 3 S Y 09-May-2008
N022185 Taclonex Scalp calcipotriene;betamethasone dipropionate Leo Pharm Products 3 S Y 09-May-2008
N021775 Entereg alvimopan Adolor 1 S Y 20-May-2008
N022104 Venlafaxine hydrochloride venlafaxine hydrochloride Osmotica 3 S Y 20-May-2008
N021830 Asacol mesalamine Proctor & Gamble 3 S Y 29-May-2008
N022008 Requip XL ropinirole SmithKline Beecham 3 S   13-Jun-2008
N021952 Claritin Liqui-Gels loratadine Schering-Plough 3 S Y 16-Jun-2008
N022220 Trivaria triamcinolone acetonide Allergan 3 S Y 16-Jun-2008
N021822 Aptivus tipranavir Boehringer Ingelheim 3 P Y 23-Jun-2008
N022212 Durezol difluprednate Sirion 1 P   23-Jun-2008
N022292 Aptivus tipranavir Boehringer Ingelheim 3 P Y 23-Jun-2008
N022386 PrandiMet repaglinide/metformin hydrochloride Novo Nordisk 4 S Y 23-Jun-2008
N022260 Epoprostenol sodium epoprostenol sodium GeneraMedix 5 S Y 27-Jun-2008
N022090 Eovist gadoxetate disodium Bayer 1 S Y 03-Jul-2008
N022193 Navstel hypromellose, dextrose and glutathione Alcon 3 S Y 24-Jul-2008
N022276 Nicardipine Hydrochloride nicardipine hydrochloride Teva 5 S Y 24-Jul-2008
N022152 Stavzor valproic acid Banner 3 S Y 29-Jul-2008
 
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 505(b)(2) Approval Date
NO21837

Stavudine;Lamivudine;Nevirapine

stavudine;lamivudine;nevirapine

Strides

4 P Y 20-Mar-2008
NO22177

Stavudine;Lamivudine;Nevirapine

stavudine;lamivudine;nevirapine

Strides

4 P Y 20-Mar-2008
NO22167

Lamivudine;Stavudine

Lamivudine;Stavudine

Cipla Limited

3 P Y 19-Jun-2008

N021837 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR
N022177 stavudine 30mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR.
N022167 lamivudine 30mg/stavudine 6mg Tablets was tentatively approved on 06/19/2008 under PEPFAR.

Biologic License Application (BLA) Approvals:

BLA Number Proprietary Name Proper Name Applicant Review Classification Approval Date
125249 Arcalyst rilonacept Regeneron P,O 27-Feb-2008
125160 Cimzia certolizumab pegol CB S 22-Apr-2008

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 24, 2008

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