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Drug agency Lupin on Monday stated it has obtained approval from the US well being regulator to market Tenofovir Alafenamide tablets, used to deal with persistent hepatitis B virus an infection, within the American market. The corporate has obtained tentative approval from the US Meals and Drug Administration (FDA) for its abbreviated new drug utility for Tenofovir Alafenamide tablets (25 mg), Lupin stated in an announcement.
The Mumbai-based firm’s product is the generic equal of Gilead Sciences’ Vemlidy tablets, it added.
The product might be manufactured at firm’s Nagpur-based facility, Lupin stated.
As per IQVIA MAT December 2021, Tenofovir Alafenamide tablets had estimated annual gross sales of USD 484.2 million within the US.
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