CDER New July 13, 2017

What's New on the FDA Drugs Site

July 12, 2017

• Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Draft Agenda for Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access, July 18, 2017 (PDF 58 KB)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dexrazoxane (Zinecard) Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 12, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Fluoxetine Hydrochloride ANDA #075658	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-29	Mallinckrodt	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075658	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-29	Mallinckrodt	Labeling	Approved
Pertzye NDA #022175	Pancrelipase (Amylase;Lipase;Protease)	Capsule, Delayed Release; Oral	SUPPL-4	Digestive Care Inc	Labeling	Approved
Prasugrel ANDA #205927	Prasugrel	Tablet; Oral	ORIG-1	Mylan Pharms Inc		Approved
Vardenafil Hydrochloride ANDA #203689	Vardenafil Hydrochloride	Tablet, Orally Disintegrating; Oral	ORIG-1	Watson Labs Teva		Tentative Approval

July 11, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Adapalene ANDA #204593	Adapalene	Solution; Topical	SUPPL-1	Call Inc	Labeling	Approved
Blincyto BLA #125557	Blinatumomab	Injectable; Injection	SUPPL-8	Amgen	Efficacy	Approved
Cefuroxime Axetil ANDA #065069	Cefuroxime Axetil	Tablet; Oral	SUPPL-14	Apotex	Labeling	Approved
Enbrel BLA #103795	Etanercept	Syringe	SUPPL-5551	Immunex	Labeling	Approved
Enbrel BLA #103795	Etanercept	Vial; Subcutaneous	SUPPL-5551	Immunex	Labeling	Approved
Lupron NDA #019010	Leuprolide Acetate	Injectable; Injection	SUPPL-39	Abbvie Endocrine Inc	Labeling	Approved
Pravastatin Sodium ANDA #077917	Pravastatin Sodium	Tablet; Oral	SUPPL-17	Lupin Pharms	Labeling	Approved

 

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— Thursday, July 13, 2017 — Add Comment