USFDA: New and Generic Drug Approvals: 19 AUG 2014

New and Generic Drug Approvals

August 19, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acyclovir	acyclovir	Tablet;Oral	Zydus Pharms Usa Inc	Approval
Ammonia N 13	ammonia n 13	Injectable;Injection	Johns Hopkins Univ	Approval
Avinza	morphine sulfate	Capsule, Extended Release;Oral	King Pharms Llc	Supplement
Butrans	buprenorphine	Film, Extended Release;Transdermal	Purdue Pharma Lp	Supplement
Cerdelga	eliglustat	Capsule; Oral	Genzyme Corp	Approval
Dolophine Hydrochloride	methadone hydrochloride	Syrup;Oral	Roxane	Supplement
Dolophine Hydrochloride	methadone hydrochloride	Tablet;Oral	Roxane	Supplement
Duragesic-100	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-12	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-25	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-50	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-75	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Eliquis	apixaban	Tablet;Oral	Bristol Myers Squibb	Efficacy Supplement with Clinical Data to Support
Embeda	morphine sulfate; naltrexone hydrochloride	Capsule, Extended Release;Oral	Alpharma Pharms	Supplement
Exalgo	hydromorphone hydrochloride	Tablet, Extended Release;Oral	Mallinckrodt Inc	Supplement
Kadian	morphine sulfate	Capsule, Extended Release;Oral	Watson Labs Inc	Supplement
Ms Contin	morphine sulfate	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Mycophenolic Acid	mycophenolic acid	Tablet, Delayed Release; Oral	Apotex Inc	Approval
Mycophenolic Acid	mycophenolic acid	Tablet, Delayed Release;Oral	Apotex Inc	Approval
Nucynta Er	tapentadol hydrochloride	Tablet, Extended Release;Oral	Janssen Pharms	Supplement
Opana Er	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Endo Pharms	Supplement
Opana Er	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Endo Pharms	Supplement
Oxycontin	oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Targiniq	naloxone hydrochloride; oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Zohydro Er	hydrocodone bitartrate	Capsule, Extended Release;Oral	Zogenix Inc	Labeling Revision