CDER New July 11, 2014

What's New on the FDA Drugs Site

July 10, 2014

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA posts draft guidances describing GDUFA performance metrics and associated webinars
• Guidance for Industry:
  • ANDA Submissions — Amendments and Easily Correctable Deficiencies Under GDUFA (PDF -173KB)
  • ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 231KB)
  • Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act (PDF - 114KB)
• National Drug Code Directory
• Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS): 11 updated reports (updated)

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New and Generic Drug Approvals

July 9, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aplenzin	bupropion hydrobromide	Tablet, Extended Release;Oral	Valeant Bermuda	Labeling Revision
Cayston	aztreonam	For Solution;Inhalation	Gilead	Manufacturing Change or Addition
Fortical	calcitonin salmon recombinant	Spray, Metered;Nasal	Upsher Smith	Labeling Revision
Linzess	linaclotide	Capsule;Oral	Forest Labs Inc	Labeling Revision

 

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