CDER New November 23, 2015

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What's New on the FDA Drugs Site

 

November 20, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Ninlaro (ixazomib), new oral medication to treat multiple myeloma
• FDA Drug Shortages
  • Sumatriptan (Imitrex) Nasal Spray (New - Currently in Shortage)
• From our perspective: Ensuring the safety and effectiveness of sunscreens
• Guidance for Industry
  • Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF - 107KB)
  • Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry (PDF - 421KB)
  • Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry (PDF - 107KB) 
  • Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions To Support a GRASE Determination Under the Sunscreen Innovation Act (PDF - 124KB)
    Guidance for Industry
• National Drug Code Directory
• Postmarketing Requirements and Commitments: Downloadable Database File (updated)
• Postmarket Requirements and Commitments Search (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

November 18, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Edarbyclor	azilsartan kamedoxomil; chlorthalidone	Tablet;Oral	Arbor Pharms Ireland	Manufacturing Change or Addition
Halaven	eribulin mesylate	Solution;Intravenous	Eisai Inc	Manufacturing Change or Addition
Narcan	naloxone hydrochloride	Spray;Nasal	Adapt	Approval
Omnicef	cefdinir	Capsule;Oral	Abbvie	Labeling Revision
Omnicef	cefdinir	For Suspension;Oral	Abbvie	Labeling Revision
Trilipix	choline fenofibrate	Capsule, Delayed Release;Oral	Abbvie	Manufacturing Change or Addition
Viread	tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Manufacturing Change or Addition

 

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— Monday, November 23, 2015 — Add Comment