Drugs
Tamiflu (oseltamivir phosphate) Information
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 children aged one year and older. Efficacy of Tamiflu for the prevention of influenza has not been established in immunocompromised patients.
Related Information
- Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions
10/31/2009 - Tamiflu Oral Suspension Shortage Information
- FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension
- Emergency Compounding of an Oral Suspension from Tamiflu 75 mg Capsules (Final Concentration 15 mg/mL)
- Emergency Use of Tamiflu in Infants Less than 1 Year of Age
Updated 10/30/2009 - Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension
- Tamiflu Letter for Emergency Use Authorization (PDF - 52KB)
10/30/2009 - Tamiflu Healthcare Provider Fact Sheet (PDF - 95KB)
10/30/2009 - Tamiflu Patient Fact Sheet (PDF - 74KB)
10/30/2009 - Stockpiled Antivirals at or Nearing Expiration
10/31/2009 - Tamiflu (oseltamivir phosphate)
MedWatch Safety Alert (Posted 3/4/2008) - FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12
(12/23/2005) - Tamiflu: Consumer Questions and Answers
Labeling and Regulatory History from Drugs@FDA
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