New and Generic Drug Approvals

Visit Drugs@FDA to Search Drug Approval Reports by Month

We have changed the format of this page. You will now find approvals listed under the date of the action, rather than the date we added the information to the website.

 

 

October 19, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Rituxan	rituximab	Vial	Genentech	Labeling Revision
Rituxan	rituximab	Vial	Genentech	New Dosage Regimen

 

October 18, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atracurium Besylate	atracurium besylate	Injectable; Injection	Hospira Inc	Approval
Atracurium Besylate Preservative Free	atracurium besylate	Injectable; Injection	Hospira Inc	Approval
Cymbalta	duloxetine hydrochloride	Capsule, Delayed Rel Pellets; Oral	Lilly	Efficacy Supplement with Clinical Data to Support
Cymbalta	duloxetine hydrochloride	Capsule, Delayed Rel Pellets; Oral	Lilly	Labeling Revision
Janumet	metformin hydrochloride; sitagliptin phosphate	Tablet; Oral	Merck Sharp Dohme	Labeling Revision
Janumet Xr	metformin hydrochloride; sitagliptin phosphate	Tablet, Extended Release; Oral	Merck Sharp Dohme	Labeling Revision
Januvia	sitagliptin phosphate	Tablet; Oral	Merck Sharp Dohme	Labeling Revision
Modafinil	modafinil	Tablet; Oral	Alembic Ltd	Approval
Sclerosol	talc	Aerosol, Metered; Intrapleural	Bryan	Manufacturing Change or Addition
Singulair	montelukast sodium	Tablet; Oral	Merck	Labeling Revision
Singulair	montelukast sodium	Tablet, Chewable; Oral	Merck	Labeling Revision
Singulair	montelukast sodium	Granule; Oral	Merck	Labeling Revision
Telmisartan	telmisartan	Tablet; Oral	Glenmark Generics	Tentative Approval

 

October 17, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Adapalene	adapalene	Gel; Topical	Actavis Mid Atlantic	Tentative Approval
Alimta	pemetrexed disodium	Injectable; Iv (Infusion)	Lilly	Efficacy Supplement with Clinical Data to Support
Jetrea	ocriplasmin	Injectable; Intravitreal	Thrombogenics Inc	Approval
Kurvelo	ethinyl estradiol; levonorgestrel	Tablet; Oral-28	Lupin Ltd	Approval
Taclonex Scalp	betamethasone dipropionate; calcipotriene hydrate	Suspension; Topical	Leo Pharm Prods	Efficacy Supplement with Clinical Data to Support

 

October 16, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Azasite	azithromycin	Solution/Drops; Ophthalmic	Inspire	Manufacturing Change or Addition
Carbamazepine	carbamazepine	Capsule, Extended Release; Oral	Teva Pharms	Approval
Fludarabine Phosphate	fludarabine phosphate	Injectable; Injection	Onco Therapies Ltd	Approval
Gabapentin	gabapentin	Tablet; Oral	Invagen Pharms	Approval
Irbesartan	irbesartan	Tablet; Oral	Unichem Labs Ltd	Tentative Approval
Lamivudine; Nevirapine; Zidovudine	lamivudine; nevirapine; zidovudine	Tablet; Oral Suspension	Cipla Ltd	Tentative Approval
Nepafenac	nepafenac	Suspension; Ophthalmic	Alcon Res	Approval

 

October 15, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Carbamazepine	carbamazepine	Capsule, Extended Release; Oral	Teva Pharms	Approval
Irbesartan	irbesartan	Tablet; Oral	Roxane	Approval
Irbesartan	irbesartan	Tablet; Oral	Alembic Pharms Ltd	Approval
Irbesartan	irbesartan	Tablet; Oral	Apotex Inc	Approval
Irbesartan	irbesartan	Tablet; Oral	Lupin Ltd	Approval
Irbesartan and Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Roxane	Approval
Irbesartan and Hydrochlorothiazide	irbesartan and hydrochlorothiazide	Tablet; Oral	Alembic Ltd	Approval
Irbesartan Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Alembic Ltd	Approval
Irbesartan Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Apotex Inc	Approval
Irbesartan; Hydrochlorothiazide	irbesartan; hydrochlorothiazide	Tablet; Oral	Roxane	Approval
Ropinirole Hydrochloride	ropinirole hydrochloride	Tablet, Extended Release; Oral	Mylan Pharms Inc	Approval

 

October 12, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aripiprazole	aripiprazole	Tablet; Oral	Barr Labs Inc	Tentative Approval
Baraclude	entecavir	Tablet; Oral	Bristol Myers Squibb	Efficacy Supplement with Clinical Data to Support
Baraclude	entecavir	Solution; Oral	Bristol Myers Squibb	Efficacy Supplement with Clinical Data to Support
Bethkis	tobramycin	Solution; Inhalation	Chiesi Pharma Inc	Approval
Eloxatin	oxaliplatin	Injectable; Iv (Infusion)	Sanofi Aventis Us	Labeling Revision
Eloxatin	oxaliplatin	Injectable; Iv (Infusion)	Sanofi Aventis Us	Labeling Revision
Humalog	insulin lispro recombinant	Injectable; Injection	Lilly	Efficacy Supplement with Clinical Data to Support
Humalog Kwikpen	insulin lispro recombinant	Injectable; Injection	Lilly	Efficacy Supplement with Clinical Data to Support
Humalog Pen	insulin lispro recombinant	Injectable; Injection	Lilly	Efficacy Supplement with Clinical Data to Support
Irbesartan	irbesartan	Tablet; Oral	Watson Labs Inc	Approval
Trospium Chloride	trospium chloride	Capsule, Extended Release; Oral	Watson Labs Inc Fl	Approval

 

October 11, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Abraxane	paclitaxel	For Suspension; Iv (Infusion)	Abraxis Bioscience	New or Modified Indication
Actemra	tocilizumab	Injectable; Injection	Genentech	Efficacy Supplement with Clinical Data to Support
Combigan	brimonidine tartrate; timolol maleate	Solution/Drops; Ophthalmic	Allergan	Labeling Revision
Cubicin	daptomycin	Injectable; Iv (Infusion)	Cubist	Labeling Revision
Idarubicin Hydrochloride	idarubicin hydrochloride	Injectable; Injection	Onco Therapies Ltd	Approval
Ilaris	canakinumab	Injectable; Subcutaneous	Novartis Pharms	Labeling Revision
Omeprazole Sodium Bicarbonate	omeprazole sodium bicarbonate	Capsule; Oral	Perrigo R and D	Tentative Approval
Pioglitazone Hydrochloride; Metformin Hydrochloride	pioglitazone hydrochloride; metformin hydrochloride	Tablet; Oral	Torrent Pharms Ltd	Tentative Approval
Tretinoin	tretinoin	Cream; Topical	Precision Dermat	Approval

 

October 10, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Zydus Pharms Usa Inc	Approval
Gelnique	oxybutynin chloride	Gel; Transdermal	Watson Labs	Labeling Revision
Lunesta	eszopiclone	Tablet; Oral	Sunovion Pharms Inc	Efficacy Supplement with Clinical Data to Support
Lunesta	eszopiclone	Tablet; Oral	Sunovion Pharms Inc	Labeling Revision
Omeprazole Sodium Bicarbonate	omeprazole sodium bicarbonate	Capsule; Oral	Par Pharm	Tentative Approval
Oxytrol	oxybutynin	Film, Extended Release; Transdermal	Watson Labs (Utah)	Labeling Revision
Risedronate Sodium	risedronate sodium	Tablet; Oral	Aurobindo Pharma Ltd	Tentative Approval
Sitagliptin Phosphate	sitagliptin phosphate	Tablet; Oral	Mylan Pharms Inc	Tentative Approval

 

October 9, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Caprelsa	vandetanib	Tablet; Oral	Ipr Pharms Inc	Labeling Revision
Nexium	esomeprazole magnesium	Capsule, Delayed Rel Pellets; Oral	Astrazeneca	Labeling Revision
Nexium	esomeprazole magnesium	For Suspension, Delayed Release; Oral	Astrazeneca	Labeling Revision
Nexium	esomeprazole magnesium	For Suspension, Delayed Release; Oral	Astrazeneca	Labeling Revision
Nexium Iv	esomeprazole sodium	Injectable; Intravenous	Astrazeneca	Labeling Revision
Nicotine Polacrilex	nicotine polacrilex	Troche/Lozenge; Oral	Perrigo R and D	Approval
Prilosec	omeprazole	Capsule, Delayed Rel Pellets; Oral	Astrazeneca	Labeling Revision
Prilosec	omeprazole magnesium	For Suspension, Delayed Release; Oral	Astrazeneca	Labeling Revision
Protonix	pantoprazole sodium	Tablet, Delayed Release; Oral	Wyeth Pharms Inc	Labeling Revision
Protonix	pantoprazole sodium	For Suspension, Delayed Release; Oral	Wyeth Pharms Inc	Labeling Revision
Vimovo	esomeprazole magnesium; naproxen	Tablet, Delayed Release; Oral	Astrazeneca Lp	Labeling Revision