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What's New by Category
This page lists new and revised documents posted to the CDER web
site. Each listing will remain on this page approximately 30 days. The dates listed
indicate the dates of posting to the CDER web site, not the dates of origination or
revision. When viewing a document, click your browser's "refresh" or "reload" button to
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In the News
- FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions. Information (1/16/2009)
- Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information (1/13/2009)
- Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). Information (1/8/2009)
- On Dec. 31, 2008, Celgene issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. MedWatch Safety Alert (1/5/2009)
- FDA approves degarelix for injection for patients with advanced prostate cancer. FDA News (12/24/2008)
- ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. MedWatch Safety Information (12/24/2008)
- FDA warns consumers about tainted weight loss pills. FDA News (12/22/2008)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF] (Posted 7/31/2008)
- Warning Letters
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Last updated: January 14, 2009
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