-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/23/2011 3:56:01 PM
To: guyperea@live.com
Subject: CDER New November 22, 2011
What's New on the FDA Drugs Site
November 22, 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Drug Shortages: Current Drug Shortages: Phentolamine Mesylate for Injection
- Drug Shortages: Current Drug Shortages: Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated)
November 21, 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Drug Shortages: Current Drug Shortages: Mesna 100 mg/mL Injection (updated)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- FDA approve Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD)
- FDA Commissioner Removes Breast Cancer Indication from Avastin
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
November 22, 2011
- Leflunomide Tablets, Alembic Pharmaceuticals Ltd., Approval
- Oxaliplatin Injection, Onco Therapies Ltd., Tentative Approval
- Zortress (everolimus) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
November 21, 2011
- Eylea (aflibercept) Injection, Regeneron Pharmaceuticals, Approval
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