FDA news release 12/26 thru 12/31 "What's New (Dr

FDA news release 12/26 thru 12/31

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December 31, 2012

• Drug Firm Annual Registration Status Download File (updated)


• Drug Firm Annual Registration Status (updated)


• FDA approves Eliquis, an oral tablet used to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation


• FDA approves Fulyzaq (crofelemer), the first anti-diarrheal drug for HIV/AIDS patients


• FDA approves Sirturo (bedaquiline), the first drug to treat multi-drug resistant tuberculosis


• National Drug Code Directory (updated)

December 28, 2012

• ANDA Checklist for Completeness and Acceptability (updated)


• Current Drug Shortages Index (updated)


• Drug Firm Annual Registration Status Download File (updated)


• Drug Firm Annual Registration Status (updated)


• Drugs@FDA Download File (updated)


• Manual of Policies and Procedures (MAPP) 4516.1 Criteria for Developing and Publishing Digital Content on the CDER External Web Site (PDF - 604KB)


• National Drug Code Directory (updated)

December 27, 2012

• Current Drug Shortages Index (updated)


• Paragraph IV Patent Certifications (updated)

December 26, 2012

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  FDA approves Juxtapid (lomitapide), a new orphan drug for a rare cholesterol disorder
  
  


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  MedWatch Safety Alert: Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets
  
  


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  Spanish FDA Drug Safety Communication: Pradaxa (dabigatrán etexilato mesilato) no se debe usar en pacientes con válvulas protésicas del corazón
  
  


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  FDA Drug Safety Podcast: Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin