Pharmaceutical company Lupine announced Monday that it has received approval from the US Food and Drug Administration to commercialize tenofovir alafenamide tablets in the US market to treat chronic hepatitis B virus infection.
The company has received provisional approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tenofovir alafenamide tablets (25 mg), Lupine 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 the company’s facility in Nagpur, Lupine said.
According to IQVIA MAT December 2021, tenofovir alafenamide tablets had an estimated annual sales of £484.2 million in the US
