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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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  • CDER 2007 Update: Improving Public Health Through Human Drugs
  • Facts@FDA Download available Structured Product Labeling



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Page Last Updated: January 13, 2009

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