CDER New August 8, 2016

What's New on the FDA Drugs Site

 

August 5, 2016

• 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Small Business Regulatory Education for Industry (REdI) Conference September 2016
• FDA Drug Shortages
  • Tigecycline (Tygacil) Injection (Updated - Currently in Shortage)
• National Drug Code Directory
• Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (PDF - 565KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

August 4, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Depo-Subq Provera 104	medroxyprogesterone acetate	Injectable;Subcutaneous	Pharmacia and Upjohn	Manufacturing Change or Addition
Duloxetine Hydrochloride	duloxetine hydrochloride	Capsule, Delayed Rel Pellets;Oral	Hetero Labs Ltd Iii	Approval
Fragmin	dalteparin sodium	Injectable;Injection	Pfizer Inc	Labeling Revision
Fragmin	dalteparin sodium	Injectable;Subcutaneous	Pfizer Inc	Labeling Revision
Kyprolis	carfilzomib	Powder;Intravenous	Onyx Therap	Labeling Revision
Pancreaze	pancrelipase (amylase;lipase;protease)	Capsule, Delayed Release;Oral	Janssen Pharms	Manufacturing Change or Addition
Sterile Water	sterile water for irrigation	Liquid;Irrigation	Baxter Hlthcare	Manufacturing Change or Addition
Zurampic	lesinurad	Tablet;Oral	Ardea Biosciences	Manufacturing Change or Addition

 

 

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— Monday, August 8, 2016 — Add Comment