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CDER New July 23, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 22, 2015


New and Generic Drug Approvals

July 21, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abraxane paclitaxel For Suspension;Iv (Infusion) Abraxis Bioscience Labeling Revision
Auryxia ferric citrate Tablet;Oral Keryx Biopharms Labeling Revision
Glucagon glucagon recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Heparin Sodium heparin sodium Injectable;Injection Fresenius Kabi Usa Manufacturing Change or Addition
Heparin Sodium In Plastic Container heparin sodium Injectable;Injection Fresenius Kabi Usa Manufacturing Change or Addition
Heparin Sodium Preservative Free heparin sodium Injectable;Injection Fresenius Kabi Usa Manufacturing Change or Addition
Xtandi enzalutamide Capsule;Oral Astellas Efficacy Supplement with Clinical Data to Support
Ziagen abacavir sulfate Tablet;Oral Viiv Hlthcare Manufacturing Change or Addition

 

July 20, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Ak-Fluor 10% fluorescein sodium Injectable;Intravenous Akorn Manufacturing Change or Addition
Ak-Fluor 25% fluorescein sodium Injectable;Intravenous Akorn Manufacturing Change or Addition
Akynzeo netupitant; palonosetron hydrochloride Capsule;Oral Helsinn Hlthcare Manufacturing Change or Addition
Aricept donepezil hydrochloride Tablet;Oral Eisai Inc Labeling Revision
Aricept donepezil hydrochloride Tablet;Oral Eisai Inc Labeling Revision
Aricept Odt donepezil hydrochloride Tablet, Orally Disintegrating;Oral Eisai Inc Labeling Revision
Azilect rasagiline mesylate Tablet;Oral Teva Manufacturing Change or Addition
Bimatoprost bimatoprost Solution/Drops;Ophthalmic Apotex Inc Approval
Nesina alogliptin benzoate Tablet;Oral Takeda Pharms Usa Manufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 3% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 5% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Tradjenta linagliptin Tablet;Oral Boehringer Ingelheim Manufacturing Change or Addition
Viekira Pak (Copackaged) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir Tablet, Tablet;Oral Abbvie Inc Labeling Revision

 


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