USFDA: New and Generic Drug Approvals: 27 OCT 2014

New and Generic Drug Approvals

October 27, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Ammonia N 13	ammonia n 13	Injectable;Injection	Global Isotopes Llc	Approval
Azelastine Hydrochloride	azelastine hydrochloride	Spray	Roxane	Approval
Bystolic	nebivolol hydrochloride	Tablet;Oral	Forest Labs	Manufacturing Change or Addition
Carisoprodol	carisoprodol	Tablet;Oral	Orient Pharma Co Ltd	Approval
Delzicol	mesalamine	Capsule, Delayed Release;Oral	Warner Chilcott Llc	Labeling Revision
Dtpa	technetium tc-99m pentetate kit	Injectable;Injection	Draximage	Manufacturing Change or Addition
Fludeoxyglucose F-18	fludeoxyglucose f-18	Injectable;Injection	Global Isotopes Llc	Approval
Fluocinonide	fluocinonide	Cream;Topical	Taro	Manufacturing Change or Addition
Ivermectin	ivermectin	Tablet;Oral	Edenbridge Pharma Llc	Approval
Lyrica	pregabalin	Solution;Oral	Novel Labs Inc	Tentative Approval
Methylphenidate Hydrochloride	methylphenidate hydrochloride	Capsule, Extended Release;Oral	Barr Labs Inc	Approval
Nasonex	mometasone furoate monohydrate	Spray, Metered;Nasal	Merck Sharp Dohme	Manufacturing Change or Addition
Nevirapine	nevirapine	Tablet, Extended Release;Oral	Mylan Pharms Inc	Approval
Orfadin	nitisinone	Capsule;Oral	Swedish Orphan	Manufacturing Change or Addition
Oxymorphone Hydrochloride	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Par Pharm Inc	Approval
Ritalin La	methylphenidate hydrochloride	Capsule, Extended Release;Oral	Novartis	Manufacturing Change or Addition
Sodium Fluoride F-18	sodium fluoride f-18	Injectable;Injection	Global Isotopes Llc	Approval
Trandate	labetalol hydrochloride	Tablet;Oral	Prometheus Labs	Manufacturing Change or Addition
Ultram Er	tramadol hydrochloride	Tablet, Extended Release;Oral	Valeant Intl	Manufacturing Change or Addition
Zyflo Cr	zileuton	Tablet, Extended Release;Oral	Chiesi Usa Inc	Manufacturing Change or Addition