Tamiflu (oseltamivir phosphate)

FDA approved Tamiflu (oseltamivir phosphate), an oral anti-viral drug for the treatment of uncomplicated influenza in patients one year and older whose flu symptoms have not lasted more than two days. This product is approved to treat Type A and B influenza; however, the majority of patients included in the studies were infected with type A, the most common in the U.S.  Efficacy of Tamiflu in the treatment of influenza in subjects with chronic cardiac disease and/or respiratory disease has not been established.

Tamiflu is also approved for the prevention of influenza in adults and adolescents older than 13 years.  Efficacy of Tamiflu for the prevention of influenza has not been established in immunocompromised patients.

• Tamiflu Approval, Review, and Labeling Information (from Drugs@FDA)
• MedWatch Safety Alert: New preclinical safety data suggest that Tamiflu is not indicated for either treatment or prophylaxis of influenza in infants less than one year of age. (Posted 1/6/2004)
  • 12/2003 Dear Health Care Professional Letter
  • MedWatch Safety Information
  • Summary of Pediatric Studies Review
• Consumer Drug Information Sheet.
• FDA Talk Paper.  (Issued: 11/20/00)
• Division Director's Memorandum. (Issued: 10/25/1999)  This memorandum states the Director's rationale for recommending approval of Tamiflu for treatment of uncomplicated influenza, plus comments on the noteworthy aspects of the application.
• FDA Talk Paper.  (Issued: 10/27/99)

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Date created: Oct 10, 1999, Last updated: 1/6/2004

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