Shilpa Medicare gets USFDA nod for Tenofovir Alafenamide Tablets
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New Delhi: Shilpa Medicare has recently announced that the Company has received U.S Food and Drug Administration (USFDA) tentative approval for its Abbreviated New Drug Application (ANDA), Tenofovir Alafenamide Tablets, 25 mg on 15 Sep 2022.
The ANDA was filed as 'First to File' submission on NCE -1 date.
Tenofovir Alafenamide Tablets, 25 mg is a generic equivalent of reference listed drug (RLD) Vemlidy tablets, of Gilead Sciences Inc. used in the treatment of chronic hepatitis B virus infection as recommended in the label approved by FDA.
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