New and Generic Drug Approvals

June 5, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Alsuma	sumatriptan succinate	Injectable;Subcutaneous	Meridian Medcl	Labeling Revision
Complera	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Labeling Revision
Exparel	bupivacaine	Injectable, Liposomal;Injection	Pacira Pharms Inc	Manufacturing Change or Addition
Fioricet W/ Codeine	acetaminophen; butalbital; caffeine; codeine phosphate	Capsule;Oral	Watson Labs Inc	Manufacturing Change or Addition
Invokana	canagliflozin	Tablet;Oral	Janssen Pharms	Manufacturing Change or Addition
Lioresal	baclofen	Injectable;Intrathecal	Medtronic Neuro	Manufacturing Change or Addition
Lovaza	omega-3-acid ethyl esters	Capsule;Oral	Smithkline Beecham	Manufacturing Change or Addition
Methoxsalen	methoxsalen	Capsule;Oral	Strides Arcolab Ltd	Approval
Oxycodone Hydrochloride	oxycodone hydrochloride	Solution;Oral	Coastal Pharms	Approval
Procardia Xl	nifedipine	Tablet, Extended Release;Oral	Pfizer	Manufacturing Change or Addition
Risperdal Consta	risperidone	Injectable;Intramuscular	Janssen Pharms	Manufacturing Change or Addition
Septocaine	articaine hydrochloride; epinephrine bitartrate	Injectable;Injection	Deproco	Manufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container	sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Suboxone	buprenorphine hydrochloride; naloxone hydrochloride	Film;Sublingual	Reckitt Benckiser	Manufacturing Change or Addition
Voltaren	diclofenac sodium	Tablet, Delayed Release;Oral	Novartis	Manufacturing Change or Addition
Voltaren-Xr	diclofenac sodium	Tablet, Extended Release;Oral	Novartis	Manufacturing Change or Addition