CDER New July 23, 2015

What's New on the FDA Drugs Site

July 22, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Safety Oversight Board Meeting, May 21, 2015, Public Summary
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefepime Injection (New - Currently in Shortage)
  • Levetiracetam (Keppra) Injection (New - Currently in Shortage)
• Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry (PDF - 197KB)
• National Drug Code Directory
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
• Pediatric Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)

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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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— Thursday, July 23, 2015 — Add Comment