FDA approves first Tamiflu generic

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced that it had approved the first generic version of Tamiflu (oseltamivir phosphate) earlier this week. The drug is used to treat influenza A and B in patients two weeks of age and older who have had flu symptoms for no more than 48 hours. 

 

The generic, from Natco Pharma and Alvogen, has been approved in 30-, 45- and 75-mg dosage strengths. The drug had U.S. sales of about $403 million for the 12 months ended December 2015, according to IMS Health. Alvogen will be able to market the drug before the period of pediatric exclusivity on Tamiflu expires on Feb. 23, 2017.