New and Generic Drug Approvals

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June 5, 2014

Drug NameActive Ingredient Dosage Form/RouteSponsor Submission Type
Alsuma sumatriptan succinateInjectable;Subcutaneous Meridian MedclLabeling Revision
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;OralGilead Sciences Inc Labeling Revision
Exparel bupivacaineInjectable, Liposomal;Injection Pacira Pharms IncManufacturing Change or Addition
Fioricet W/ Codeine acetaminophen; butalbital; caffeine; codeine phosphateCapsule;Oral Watson Labs IncManufacturing Change or Addition
Invokana canagliflozinTablet;Oral Janssen PharmsManufacturing Change or Addition
Lioresal baclofenInjectable;Intrathecal Medtronic NeuroManufacturing Change or Addition
Lovaza omega-3-acid ethyl estersCapsule;Oral Smithkline BeechamManufacturing Change or Addition
Methoxsalen methoxsalenCapsule;Oral Strides Arcolab LtdApproval
Oxycodone Hydrochloride oxycodone hydrochlorideSolution;Oral Coastal PharmsApproval
Procardia Xl nifedipineTablet, Extended Release;Oral PfizerManufacturing Change or Addition
Risperdal Consta risperidoneInjectable;Intramuscular Janssen PharmsManufacturing Change or Addition
Septocaine articaine hydrochloride; epinephrine bitartrateInjectable;Injection DeprocoManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container sodium chlorideInjectable;Injection Baxter HlthcareManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chlorideInjectable;Injection Baxter HlthcareManufacturing Change or Addition
Suboxone buprenorphine hydrochloride; naloxone hydrochlorideFilm;Sublingual Reckitt BenckiserManufacturing Change or Addition
Voltaren diclofenac sodiumTablet, Delayed Release;Oral NovartisManufacturing Change or Addition
Voltaren-Xr diclofenac sodiumTablet, Extended Release;Oral NovartisManufacturing Change or Addition

 

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