Posted On: 01/01/2013 5:29:22 PM
Post# of 63821
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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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
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