Drug firm Lupin on Monday said it has received approval from the U.S. health regulator to market Tenofovir Alafenamide tablets, used to treat chronic hepatitis B virus infection, in the American market.
The company has received tentative approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application for Tenofovir Alafenamide tablets (25 mg), Lupin said in a statement.
The Mumbai-based company’s product is the generic equivalent of Gilead Sciences’ Vemlidy tablets, it added.
The product will be manufactured at company’s Nagpur-based facility, Lupin said.
As per IQVIA MAT December 2021, Tenofovir Alafenamide tablets had estimated annual sales of ₹484.2 million in the U.S.