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News from CDER

 May 16. FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix). Drug Information.

 May 16. FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic). Drug Information.

 May 14. Manufacturer Removes Remaining Stocks of Trasylol. FDA News and Information.

 May 14. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass. Information.

 May 14. FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime). Information

 May 12. FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information

 May 2. The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information.

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Page Last Updated: May 16, 2008

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