USFDA: New and Generic Drug Approvals: 08 OCT 2014

New and Generic Drug Approvals

October 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Eurax crotamiton Lotion;Topical Ranbaxy Manufacturing Change or Addition
Olopatadine Hydrochloride olopatadine hydrochloride Solution;Nasal Apotex Inc Approval
Otrexup methotrexate Solution;Subcutaneous Antares Pharma Inc Manufacturing Change or Addition
Tamiflu oseltamivir phosphate Capsule;Oral Roche Manufacturing Change or Addition
Velcade bortezomib Injectable;Intravenous, Subcutaneous Millennium Pharms Efficacy Supplement with Clinical Data to Support

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