USFDA: New and Generic Drug Approvals: 20 NOV 2014

New and Generic Drug Approvals

November 20, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aleve Pm	diphenhydramine hydrochloride; naproxen sodium	Tablet;Oral	Bayer Hlthcare	Labeling Revision
Avelox	moxifloxacin hydrochloride	Tablet;Oral	Bayer Hlthcare	Labeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Container	moxifloxacin hydrochloride	Injectable;Iv (Infusion)	Bayer Hlthcare	Labeling Revision
Biltricide	praziquantel	Tablet;Oral	Bayer Hlthcare	Manufacturing Change or Addition
Carac	fluorouracil	Cream;Topical	Valeant Bermuda	Manufacturing Change or Addition
Dalvance	dalbavancin hydrochloride	Injectable;Iv (Infusion)	Durata Theraps Intl	Manufacturing Change or Addition
Depacon	valproate sodium	Injectable;Injection	Abbvie	Labeling Revision
Depakene	valproic acid	Capsule;Oral	Abbvie	Labeling Revision
Depakene	valproic acid	Syrup;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Tablet, Delayed Release;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Capsule, Delayed Rel Pellets;Oral	Abbvie	Labeling Revision
Depakote Er	divalproex sodium	Tablet, Extended Release;Oral	Abbvie	Labeling Revision
Finasteride	finasteride	Tablet;Oral	Cipla Ltd	Approval
Gliadel	carmustine	Implant;Intracranial	Arbor Pharms Llc	Labeling Revision
Hysingla Er	hydrocodone bitartrate	Tablet, Extended Release;Oral	Purdue Pharma	Approval
Isordil	isosorbide dinitrate	Tablet;Oral	Valeant Bermuda	Manufacturing Change or Addition
Jenloga	clonidine hydrochloride	Tablet, Extended Release;Oral	Concordia Pharms Inc	Efficacy Supplement with Clinical Data to Support
Kapvay	clonidine hydrochloride	Tablet, Extended Release;Oral	Concordia Pharms Inc	Efficacy Supplement with Clinical Data to Support
Locoid Lipocream	hydrocortisone butyrate	Cream;Topical	Precision Dermat	Labeling Revision
Priftin	rifapentine	Tablet;Oral	Sanofi Aventis Us	Labeling Revision
Stendra	avanafil	Tablet;Oral	Vivus	Manufacturing Change or Addition