Subject: CDER New: November 10, 2011
Date: Thu, 10 Nov 2011 09:54:42 -0600
To: guyperea@live.com
From: fda@service.govdelivery.com
What's New on the FDA Drugs Site
November 9, 2011
- Acronyms and Abbreviations Database File Download (updated)
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
- Comunicado de la FDA sobre la seguridad de los medicamentos: INFORMACIÓN ACTUALIZADA sobre agentes bloqueadores del factor de necrosis tumoral (TNF por sus siglas en inglés) y riesgos de tumores malignos en niños
- FDA Drug Safety Communication: Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection
- Drugs@FDA Download File (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
November 9, 2011
- Naprelan (naproxen sodium) Controlled-Release Tablets, Stat-Trade, Inc., Labeling Revision
- Naproxen Tablets, Aurobindo Pharmaceuticals USA, Inc., Approval
- Savella (Milnacipran hydrochloride) Tablets, Crypress Bioscience, Inc., Labeling Revision
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