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News from CDER

January 16 FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions. Information

January 13. Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair). Information

January 8. 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

December 31. Celgene issues 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


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Page Last Updated: January 13, 2009

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