CDER New March 17, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

March 14, 2014


New and Generic Drug Approvals

March 13, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Astelin azelastine hydrochloride Spray, Metered;Nasal Meda Pharms Manufacturing Change or Addition
Astepro azelastine hydrochloride Spray, Metered;Nasal Meda Pharms Manufacturing Change or Addition
Clindamycin Palmitate Hydrochloride clindamycin palmitate hydrochloride For Solution;Oral Amneal Pharms Approval
Docetaxel docetaxel Injectable;Injection Pfizer Approval
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Efficacy Supplement with Clinical Data to Support
Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection Hospira Labeling Revision
Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection Hospira Labeling Revision
Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection Hospira Labeling Revision
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection Hospira Labeling Revision
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection Hospira Labeling Revision
Myrbetriq mirabegron Tablet, Extended Release;Oral Apgdi Manufacturing Change or Addition
Noxafil posaconazole Injectable;Injection Merck Sharp Dohme Approval
Sodium Fluoride F-18 sodium fluoride f-18 Injectable; Injection Ucsf Radiopharmaceutical Facility Approval
Taclonex betamethasone dipropionate; calcipotriene hydrate Ointment;Topical Leo Pharma As Manufacturing Change or Addition
Velcade bortezomib Injectable;Intravenous, Subcutaneous Millennium Pharms Manufacturing Change or Addition
Vibativ telavancin hydrochloride Powder;Iv (Infusion) Theravance Inc Manufacturing Change or Addition

 


This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery