FDA Green Lights Generic Version of Oseltamivir Phosphate

Officials with the US Food and Drug Administration have approved the first generic version of oseltamivir phosphate (Tamiflu), to treat influenza A and B in patients 2 weeks of age and older.

The medication is indicated for those patients who have had influenza symptoms less than 48 hours. Adverse events reported by people using oseltamivir phosphate in clinical trials included nausea and vomiting.

In a postmarket statement, FDA officials noted: “Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with the flu. The FDA does not know if oseltamivir phosphate is effective in people who start treatment after two days of developing symptoms, or have weakened immune systems.”

Reference

FDA.  The FDA approves first generic version of widely used influenza drug, Tamiflu. Postmarket Drug Safety Information. 2016.