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US FDA grants priority review for Mallinckrodt's pain relief drug


The US Food and Drug Administration has accepted and granted a priority review for the New Drug Application…

DepomedMallinckrodtNorth AmericaOxycodone and AcetaminophenPharmaceuticalRegulation

Briefs: Depomed drops Sefelsa after CRL: Sun Pharma stalking Meda?


US specialty drugmaker Depomed (Nasdaq: DEPO) says that Food and Drug Administration issued a complete…

DepomedMedaMergers & AcquisitionsMetabolicsNorth AmericaPharmaceuticalRegulationResearchSefelsaSun Pharmaceutical Industries

FDA should not approve paroxetine or gabapentin for hot flashes, says Public Citizen


A drug approved to treat depression and other mental health disorders and another designed to prevent…

DepomedgabapentinHisamitsu PharmaNorth AmericaparoxetinePharmaceuticalRegulationWomen's Health

Depomed to file NDA for Serada; with Valeant sues Watson over Glumetza


US drugmaker Depomed (Nasdaq: DEPO) says that it has completed a Type B pre-New Drug Application meeting…

DepomedDiabetesGenericsGlumetzaNorth AmericaPatentsPharmaceuticalRegulationResearchSeradaValeant PharmaceuticalsWatson PharmaceuticalsWomen's Health

Mylan debuts Lescol copy; Impax challenges Gralise patent


US generic drug major Mylan (Nasdaq: MYL) revealed last Friday that it has begun shipping its generic…

Cardio-vascularDepomedGenericsGraliseImpax LaboratoriesLescolMarkets & MarketingMylan LaboratoriesNeurologicalNorth AmericaNovartisPatentsRegulation

US FDA clears use of Novartis’ Menveo for over two-year-olds; Depomed leaps on approval of shingles drug Gralise


The US Food and Drug Administration has approved Swiss drug major Novartis’ (NOVN: VX) Menveo (meningococcal…

Abbott LaboratoriesDepomedGraliseMenveoNeurologicalNorth AmericaNovartisPharmaceuticalRegulationVaccines

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