USFDA approves Lupin’s tablets for Hepatitis B infection treatment

Global pharma major Lupin Limited on Friday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tenofovir Alafenamide Tablets, 25 mg.

It is a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc. This product will be manufactured at Lupin’s Nagpur facility in India.

The drug is approved for the treatment of chronic Hepatitis B infection in adults.

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Tenofovir Alafenamide Tablets, 25 mg, (RLD Vemlidy) had estimated annual sales of USD 531 million in the U.S. (IQVIA MAT December 2022).