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 4, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Diovan	valsartan	Tablet; Oral	Novartis	Labeling Revision
Diovan Hct	hydrochlorothiazide; valsartan	Tablet; Oral	Novartis	Labeling Revision
Edarbi	azilsartan kamedoxomil	Tablet; Oral	Takeda Pharms Usa	Labeling Revision
Jevtana Kit	cabazitaxel	Solution; Iv (Infusion)	Sanofi Aventis Us	Labeling Revision
Timentin	clavulanate potassium; ticarcillin disodium	Injectable; Injection	Glaxosmithkline	Labeling Revision
Timentin In Plastic Container	clavulanate potassium; ticarcillin disodium	Injectable; Injection	Glaxosmithkline	Labeling Revision
Tracleer	bosentan	Tablet; Oral	Actelion Pharms Ltd	Efficacy Supplement with Clinical Data to Support

 

October 3, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Irbesartan	irbesartan	Tablet; Oral	Macleods Pharms Ltd	Approval
Oxcarbazepine	oxcarbazepine	Suspension; Oral	Roxane	Approval

 

October 2, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cystaran	cysteamine	Solution; Ophthalmic	Sigma Tau	Approval
Edarbi	azilsartan kamedoxomil	Tablet; Oral	Takeda Pharms Usa	Labeling Revision
Edarbyclor	azilsartan kamedoxomil; chlorthalidone	Tablet; Oral	Takeda Pharms Usa	Labeling Revision
Imitrex	sumatriptan succinate	Injectable; Subcutaneous	Glaxosmithkline	Labeling Revision
Imitrex Statdose	sumatriptan succinate	Injectable; Subcutaneous	Glaxosmithkline	Labeling Revision
Zortress	everolimus	Tablet; Oral	Novartis	Labeling Revision
Zylet	loteprednol etabonate; tobramycin	Suspension/Drops; Ophthalmic	Bausch and Lomb	Labeling Revision

 

October 1, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Albuterol Sulfate and Ipratropium Bromide	albuterol sulfate; ipratropium bromide	Solution; Inhalation	Ritedose Corp	Approval
Fluoxetine Hydrochloride	fluoxetine hydrochloride	Capsule; Oral	Heritage Pharms Inc	Approval

 

September 28, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amturnide	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	Tablet; Oral	Novartis	Labeling Revision
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	cetirizine hydrochloride; pseudoephedrine hydrochloride	Tablet, Extended Release; Oral	Sun Pharm Inds Ltd	Approval
Colistimethate Sodium	colistimethate sodium	Injectable; Injection	Emcure Pharms Ltd	Approval
Desoximetasone	desoximetasone	Ointment; Topical	Fougera Pharms	Approval
Dexilant	dexlansoprazole	Capsule, Delayed Release; Oral	Takeda Pharms	Labeling Revision
Diltiazem Hydrochloride	diltiazem hydrochloride	Capsule, Extended Release; Oral	Actavis Elizabeth	Approval
Exforge	amlodipine besylate; valsartan	Tablet; Oral	Novartis	Labeling Revision
Exforge HCT	amlodipine besylate; hydrochlorothiazide; valsartan	Tablet; Oral	Novartis	Labeling Revision
Hydrochlorothiazide; Irbesartan	hydrochlorothiazide; irbesartan	Tablet; Oral	Cipla Limited	Tentative Approval
Indomethacin	indomethacin	Capsule, Extended Release; Oral	Hetero Labs Ltd Iii	Approval
Lotemax	loteprednol etabonate	Gel; Ophthalmic	Bausch and Lomb	Approval
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
Pantoprazole Sodium	pantoprazole sodium	Tablet, Delayed Release; Oral	Aurobindo Pharma Ltd	Approval
Phentermine Hydrochloride	phentermine hydrochloride	Capsule; Oral	Elite Labs	Approval
Prevacid	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Takeda Pharms USA	Labeling Revision
Prevacid	lansoprazole	Tablet, Delayed Release, Orally Disintegrating; Oral	Takeda Pharms USA	Labeling Revision
Prilosec	omeprazole	Capsule, Delayed Rel Pellets; Oral	Astrazeneca	Labeling Revision
Prilosec	omeprazole magnesium	For Suspension, Delayed Release; Oral	Astrazeneca	Labeling Revision
Progesterone	progesterone	Capsule; Oral	Sofgen Pharms	Approval
Protonix Iv	pantoprazole sodium	Injectable; Iv (Infusion)	Wyeth Pharms Inc	Labeling Revision
Quinine Sulfate	quinine sulfate	Capsule; Oral	Teva Pharms	Approval
Tacrolimus	tacrolimus	Capsule; Oral	Panacea Biotec Ltd	Approval
Tekamlo	aliskiren hemifumarate; amlodipine besylate	Tablet; Oral	Novartis	Labeling Revision
Tekturna	aliskiren hemifumarate	Tablet; Oral	Novartis	Labeling Revision
Tekturna HCT	aliskiren hemifumarate; hydrochlorothiazide	Tablet; Oral	Novartis	Labeling Revision
Tradjenta	linagliptin	Tablet; Oral	Boehringer Ingelheim	Efficacy Supplement with Clinical Data to Support

 

September 27, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Digoxin	digoxin	Elixir; Oral	Roxane	Labeling Revision
Foradil	formoterol fumarate	Powder; Inhalation	Novartis	Labeling Revision
Irbesartan	irbesartan	Tablet; Oral	Sandoz	Approval
Irbesartan	irbesartan	Tablet; Oral	Zydus Pharms USA Inc	Approval
Irbesartan	irbesartan	Tablet; Oral	Mylan Pharms Inc	Approval
Irbesartan	irbesartan	Tablet; Oral	Prinston Inc	Approval
Irbesartan	irbesartan	Tablet; Oral	Aurobindo Pharma Ltd	Approval
Irbesartan	irbesartan	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Irbesartan and Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Sandoz	Approval
Irbesartan and Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Mylan Pharms Inc	Approval
Irbesartan and Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Macleods Pharms Ltd	Approval
Irbesartan and Hydrochlorothiazide	hydrochlorothiazide; irbesartan	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Irbesartan; Hydrochlorothiazide	irbesartan: hydrochlorothiazide	Tablet; Oral	Macleods Pharms Ltd	Approval
Modafinil	modafinil	Tablet; Oral	Aurobindo Pharma Ltd	Approval
Quillivant Xr	methylphenidate hydrochloride	Suspension; Oral	Nextwave Pharms Inc	Approval
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
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Injectable; Injection	Medefil	Labeling Revision
Sorilux	calcipotriene	Aerosol, Foam; Topical	Stiefel Labs Inc	Labeling Revision
Stivarga	regorafenib	Tablet; Oral	Bayer Healthcare Pharms	Approval

 

September 26, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Arcapta Neohaler	indacaterol maleate	Powder; Inhalation	Novartis	Labeling Revision
Modafinil	modafinil	Tablet; Oral	Orchid Hlthcare	Approval
Modafinil	modafinil	Tablet; Oral	Hikma Pharms	Approval
Pioglitazone Hydrochloride	pioglitazone hydrochloride	Tablet; Oral	Macleods Pharms Ltd	Tentative Approval
Pioglitazone Hydrochloride; Metformin Hydrochloride	pioglitazone hydrochloride; metformin hydrochloride	Tablet; Oral	Aurobindo Pharma Ltd	Tentative Approval
Pregabalin	pregabalin	Capsule; Oral	Wockhardt Usa	Tentative Approval
Sildenafil Citrate	sildenafil citrate	Tablet; Oral	Dr Reddys Labs Ltd	Tentative Approval
Vinorelbine Tartrate	vinorelbine tartrate	Injectable; Injection	Jiangsu Hansoh Pharma	Approval

 

September 25, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amlodipine,Valsartan and Hydrochlorothiazide	amlodipine; hydrochlorothiazide; valsartan	Tablet; Oral	Teva Pharms	Approval
Cellcept	mycophenolate mofetil	Capsule; Oral	Roche Palo	Labeling Revision
Cellcept	mycophenolate mofetil	Tablet; Oral	Roche Palo	Labeling Revision
Cellcept	mycophenolate mofetil hydrochloride	Injectable; Injection	Roche Palo	Labeling Revision
Cellcept	mycophenolate mofetil	Suspension; Oral	Roche Palo	Labeling Revision
Entereg	alvimopan	Capsule; Oral	Cubist Pharms	Labeling Revision
Ethosuximide	ethosuximide	Capsule; Oral	Zydus Pharms Usa Inc	Approval
Jentadueto	linagliptin; metformin hydrochloride	Tablet; Oral	Boehringer Ingelheim	Labeling Revision
Myfortic	mycophenolic acid	Tablet, Delayed Release; Oral	Novartis	Labeling Revision
Perforomist	formoterol fumarate	Solution; Inhalation	Dey Pharma	Labeling Revision
Tolterodine Tartrate	tolterodine tartrate	Tablet; Oral	Apotex Corp	Approval

 

September 24, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aprepitant	aprepitant	Capsule; Oral	Sandoz	Approval
Cayston	aztreonam	For Solution; Inhalation	Gilead	Labeling Revision
Cilostazol	cilostazol	Tablet; Oral	Biokey	Approval
Cilostazol	cilostazol	Tablet; Oral	Biokey	Approval
Hydrochlorothiazide	hydrochlorothiazide	Tablet; Oral	Accord Hlthcare	Approval
Losartan Potassium	losartan potassium	Tablet; Oral	Micro Labs Ltd India	Approval
Methscopolamine Bromide	methscopolamine bromide	Tablet; Oral	Bayshore Pharms Llc	Approval

 

September 21, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Accupril	quinapril hydrochloride	Tablet; Oral	Pfizer Pharms	Labeling Revision
Accuretic	hydrochlorothiazide; quinapril hydrochloride	Tablet; Oral	Pfizer Pharms	Labeling Revision
Celecoxib	celecoxib	Capsule; Oral	Watson Labs Inc	Tentative Approval
Eylea	aflibercept	Injectable; Injection	Regeneron Pharmaceuticals	Efficacy Supplement with Clinical Data to Support
Lamivudine; Nevirapine; Zidovudine	lamivudine; nevirapine; zidovudine	Tablet, For Suspension; Oral	Strides Arcolab Ltd	Tentative Approval
Lotensin	benazepril hydrochloride	Tablet; Oral	Novartis	Labeling Revision
Lotensin Hct	benazepril hydrochloride; hydrochlorothiazide	Tablet; Oral	Novartis	Labeling Revision
Montelukast Sodium	montelukast sodium	Tablet; Oral	Accord Hlthcare	Approval
Phentermine Hydrochloride	phentermine hydrochloride	Tablet; Oral	Mirror Pharms	Approval
Valsartan and Hydrochlorothiazide	hydrochlorothiazide; valsartan	Tablet; Oral	Mylan Pharms Inc	Approval
Venofer	iron sucrose	Injectable; Intravenous	Luitpold	Efficacy Supplement with Clinical Data to Support

 

September 20, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Androgel	testosterone	Gel, Metered; Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel; Transdermal	Abbvie	Labeling Revision
Carbamazepine	carbamazepine	Capsule, Extended Release; Oral	Teva Pharms	Approval
Carbamazepine	carbamazepine	Capsule, Extended Release; Oral	Teva Pharms Usa	Tentative Approval
Glycopyrrolate	glycopyrrolate	Tablet; Oral	Excellium	Approval
Micardis	telmisartan	Tablet; Oral	Boehringer Ingelheim	Labeling Revision
Nicoderm Cq	nicotine	Film, Extended Release; Transdermal	Sanofi Aventis Us	Labeling Revision
Pramipexole Dihydrochloride	pramipexole dihydrochloride	Tablet; Oral	Macleods Pharms Ltd	Approval
Prolia	denosumab	Injectable; Subcutaneous	Amgen	Efficacy Supplement with Clinical Data to Support
Xgeva	denosumab	Injectable; Subcutaneous	Amgen	Efficacy Supplement with Clinical Data to Support

 

September 19, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Doxil	doxorubicin hydrochloride	Injectable, Liposomal; Injection	Janssen R and D	Labeling Revision
Prevacid 24 Hr	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Novartis	Labeling Revision

 

September 18, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Benicar Hct	hydrochlorothiazide; olmesartan medoxomil	Tablet; Oral	Daiichi Sankyo	Labeling Revision
Besivance	besifloxacin hydrochloride	Suspension/Drops; Ophthalmic	Bausch and Lomb	Efficacy Supplement with Clinical Data to Support
Juvisync	simvastatin; sitagliptin phosphate	Tablet; Oral	Merck Sharp Dohme	Efficacy Supplement with Clinical Data to Support
Juvisync	simvastatin; sitagliptin phosphate	Tablet; Oral	Merck Sharp Dohme	Labeling Revision
Losartan Potassium	losartan potassium	Tablet; Oral	Cadista Pharms	Approval
Losartan Potassium and Hydrochlorothiazide	hydrochlorothiazide; losartan potassium	Tablet; Oral	Cadista Pharms	Approval
Nicorette	nicotine polacrilex	Troche/Lozenge; Oral	Glaxosmithkline Cons	Labeling Revision
Rizatriptan Benzoate	rizatriptan benzoate	Tablet; Oral	Glenmark Generics	Tentative Approval
Testosterone Enanthate	testosterone enanthate	Injectable; Injection	Hikma Farmaceutica	Approval
Zegerid Otc	omeprazole; sodium bicarbonate	Capsule; Oral	Msd Consumer	Labeling Revision

 

September 17, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aldactone	spironolactone	Tablet; Oral	Gd Searle Llc	Approval
Combivent	albuterol sulfate; ipratropium bromide	Aerosol, Metered; Inhalation	Boehringer Ingelheim	Approval
Fluocinonide	fluocinonide	Cream; Topical	Fougera Pharms	Tentative Approval
Glyset	miglitol	Tablet; Oral	Pharmacia and Upjohn	Labeling Revision
Montelukast Sodium	montelukast sodium	Granule; Oral	Dr Reddys Labs Ltd	Approval
Oxcarbazepine	oxcarbazepine	Suspension; Oral	Amneal Pharms	Approval
Zytiga	abiraterone acetate	Tablet; Oral	Janssen Biotech	Labeling Revision