CDER New July 19, 2013

What's New on the FDA Drugs Site

July 18, 2013

• Current Drug Shortages Index (updated)
  • Resolved Drug Shortages: Gabapentin Enacarbil (Horizant) Extended-Release Tablets
  • Resolved Drug Shortages: Naloxone Injection
  • Resolved Drug Shortages: Peginterferon Alpha-2A (Pegasys) Injection
  • Resolved Drug Shortages: Ticlopidine Tablets
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Statement: FDA halts clinical trial of drug Revlimid (lenalidomide) for chronic lymphocytic leukemia due to safety concerns
• Manual of Policies and Procedures (MAPP) 
  • 7400.13 (PDF - 147KB) Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information
  • 7600.10 (PDF -135KB) CDER Master Data Management
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
• National Drug Code Directory 

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New and Generic Drug Approvals

July 17, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Agrylin	anagrelide hydrochloride	Capsule; Oral	Shire Llc	Labeling Revision
Repaglinide	repaglinide	Tablet; Oral	Paddock Labs	Tentative Approval
Tretinoin	tretinoin	Gel; Topical	Spear Pharms	Approval
Tretinoin	tretinoin	Gel; Topical	Spear Pharms	Approval

 

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