The Food and Drug Administration has approved the first generic version of Tamiflu (oseltamivir phosphate), a medication for the treatment of influenza A and B.
The announcement was made Aug. 3, 2016, on the Drugs@FDA website and in an email from the FDA’s Division of Drug Information (DDI). Tamiflu was first approved in 1999.
Oseltamivir phosphate is intended for use in patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours, and for prevention of influenza in patients 1 year of age and older. According to the FDA, the drug does not treat or prevent illness caused by viral infections other than the influenza virus, and does not prevent bacterial infections that may happen with the flu.
Products in the FDA generic approval application submitted by Natco Pharma Ltd., an India-based drug company, include the oral capsule form of the drug, in 30-, 45-, and 75-mg strengths.
The FDA acknowledged in its approval that it does not know if oseltamivir phosphate is effective in patients who start treatment after 2 days of developing symptoms, or have weakened immune systems. The most common side effects reported by patients using oseltamivir phosphate in clinical trials included nausea and vomiting.
For more information on oseltamivir phosphate, see the Tamiflu drug label .
On Twitter @richpizzi