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Drugs in the News

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

December 24. FDA approves degarelix for injection for patients with advanced prostate cancer. FDA News

• December 24. 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

December 22. FDA warns consumers about tainted weight loss pills. FDA News


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Prescription Drug User Fee Act (PDUFA)
FDA proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

National Drug Code Updates
National Drug code information and updating information
Prescription Drug Marketing Act (PDMA)
Drugs Marketed in the United States That Do Not Have Required FDA Approval
FDA has issued a guidance entitled “Marketed Unapproved Drugs--Compliance Policy Guide” designed to make sure that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective.
Facts@FDA Download available Structured Product Labeling file.

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