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Tamiflu FDA Review

Review

Tamiflu (oseltamivir phosphate) is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age 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.

Tamilfu is not a substitute for early influenza vaccination on an annual basis.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.