USFDA: New and Generic Drug Approvals: 30 MAR 2015

New and Generic Drug Approvals

March 30, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aceon	perindopril erbumine	Tablet;Oral	Symplmed Pharms Llc	Labeling Revision
Advil Congestion Relief	ibuprofen; phenylephrine hydrochloride	Tablet;Oral	Pfizer	Labeling Revision
Cesamet	nabilone	Capsule;Oral	Meda Pharms	Manufacturing Change or Addition
Choline C-11	choline c-11	Injectable;Intravenous	Mcprf	Manufacturing Change or Addition
Depakote Er	divalproex sodium	Tablet, Extended Release;Oral	Abbvie	Labeling Revision
Edecrin	ethacrynic acid	Tablet;Oral	Aton	Manufacturing Change or Addition
Estrostep 21	ethinyl estradiol; norethindrone acetate	Tablet;Oral-21	Warner Chilcott Llc	Manufacturing Change or Addition
Estrostep Fe	ethinyl estradiol; norethindrone acetate	Tablet;Oral-28	Warner Chilcott Llc	Manufacturing Change or Addition
Fanapt	iloperidone	Tablet;Oral	Vanda Pharms Inc	Manufacturing Change or Addition
Omeprazole	omeprazole	Tablet, Delayed Release;Oral	Dexcel Pharma	Manufacturing Change or Addition
Pancreaze	pancrelipase (amylase;lipase;protease)	Capsule, Delayed Release;Oral	Janssen Pharms	Manufacturing Change or Addition
Qudexy Xr	topiramate	Capsule, Extended Release;Oral	Upsher Smith	Efficacy Supplement with Clinical Data to Support
Rapamune	sirolimus	Tablet;Oral	Pf Prism Cv	Manufacturing Change or Addition
Retisert	fluocinolone acetonide	Implant;Intravitreal	Bausch and Lomb	Manufacturing Change or Addition
Salonpas	menthol; methyl salicylate	Patch;Topical	Hisamitsu Pharm Co	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Solution;Irrigation	B Braun	Manufacturing Change or Addition
Solaraze	diclofenac sodium	Gel;Topical	Fougera Pharms	Manufacturing Change or Addition
Sterile Water In Plastic Container	sterile water for irrigation	Liquid;Irrigation	B Braun	Manufacturing Change or Addition
Topotecan Hydrochloride	topotecan hydrochloride	Solution;Intravenous	Teva Pharms Usa	Manufacturing Change or Addition
Urex	methenamine hippurate	Tablet;Oral	Cnty Line Pharms	Manufacturing Change or Addition
Zaroxolyn	metolazone	Tablet;Oral	Ucb Inc	Manufacturing Change or Addition

USFDA: New and Generic Drug Approvals: 27 MAR 2015

New and Generic Drug Approvals

March 27, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amturnide	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	Tablet;Oral	Novartis	Labeling Revision
Aptivus	tipranavir	Capsule;Oral	Boehringer Ingelheim	Labeling Revision
Aptivus	tipranavir	Solution;Oral	Boehringer Ingelheim	Labeling Revision
Cordarone	amiodarone hydrochloride	Tablet;Oral	Wyeth Pharms Inc	Labeling Revision
Emsam	selegiline	Film, Extended Release;Transdermal	Somerset	Labeling Revision
Eovist	gadoxetate disodium	Solution;Intravenous	Bayer Hlthcare	Efficacy Supplement with Clinical Data to Support
Invirase	saquinavir mesylate	Capsule;Oral	Hoffmann La Roche	Labeling Revision
Invirase	saquinavir mesylate	Tablet;Oral	Hoffman La Roche	Labeling Revision
Kaletra	lopinavir; ritonavir	Capsule;Oral	Abbvie	Labeling Revision
Kaletra	lopinavir; ritonavir	Solution;Oral	Abbvie	Labeling Revision
Kaletra	lopinavir; ritonavir	Tablet;Oral	Abbvie	Labeling Revision
Lexiva	fosamprenavir calcium	Tablet;Oral	Viiv Hlthcare	Labeling Revision
Lexiva	fosamprenavir calcium	Suspension;Oral	Viiv Hlthcare	Labeling Revision
Mirapex	pramipexole dihydrochloride	Tablet;Oral	Boehringer Ingelheim	Labeling Revision
Mirapex Er	pramipexole dihydrochloride	Tablet, Extended Release;Oral	Boehringer Ingelheim	Labeling Revision
Norvir	ritonavir	Capsule;Oral	Abbvie	Labeling Revision
Prezista	darunavir ethanolate	Tablet;Oral	Janssen Prods	Labeling Revision
Prezista	darunavir ethanolate	Suspension;Oral	Janssen Prods	Labeling Revision
Reyataz	atazanavir sulfate	Capsule;Oral	Bristol Myers Squibb	Labeling Revision
Reyataz	atazanavir sulfate	Powder;Oral	Bristol Myers Squibb	Labeling Revision
Saxenda	liraglutide recombinant	Solution;Subcutaneous	Novo Nordisk Inc	Labeling Revision
Sustiva	efavirenz	Capsule;Oral	Bristol Myers Squibb	Labeling Revision
Sustiva	efavirenz	Tablet;Oral	Bristol Myers Squibb	Labeling Revision
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
Viracept	nelfinavir mesylate	Powder;Oral	Agouron	Labeling Revision
Viracept	nelfinavir mesylate	Tablet;Oral	Agouron	Labeling Revision
Viracept	nelfinavir mesylate	Tablet;Oral	Agouron	Labeling Revision

USFDA: New and Generic Drug Approvals: 25 NOV 2014

New and Generic Drug Approvals

November 25, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amoxil	amoxicillin	For Suspension;Oral	Dr Reddys Labs Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Sandoz	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet;Oral	Apotex Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Sun Pharma Global	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Actavis Labs Fl Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Mylan	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Anchen Pharms	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Zydus Pharms Usa Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Jubilant Generics	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Extended Release;Oral	Reddys	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Delayed Release;Oral	Aurobindo Pharma Ltd	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Extended Release;Oral	Aurobindo Pharma Ltd	Labeling Revision
Larotid	amoxicillin	For Suspension;Oral	Dr Reddys Labs Inc	Labeling Revision
Lucentis	ranibizumab	Injectable; Injection	Genentech	Efficacy Supplement with Clinical Data to Support
Norco	acetaminophen; hydrocodone bitartrate	Tablet;Oral	Watson Labs	Labeling Revision
Priftin	rifapentine	Tablet;Oral	Sanofi Aventis Us	Efficacy Supplement with Clinical Data to Support
Topiramate	topiramate	Capsule;Oral	Zydus Pharms Usa Inc	Labeling Revision
Tussicaps	chlorpheniramine polistirex; hydrocodone polistirex	Capsule, Extended Release;Oral	Ecr Pharma	Labeling Revision