Lupin gets USFDA nod for generic equivalent of Vemlidy Tablets
This product will be manufactured at Lupin's Nagpur facility in India.;
Mumbai: Global pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tenofovir Alafenamide Tablets, 25 mg used for the treatment of chronic Hepatitis B infection.
The product is a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc.
This drug will be manufactured at Lupin's Nagpur facility in India.
Read also: Lupin unveils Contraceptive drug Merzee in US
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). It is a major global health problem. It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer. In highly endemic areas, hepatitis B is most commonly spread from mother to child at birth (perinatal transmission) or through horizontal transmission (exposure to infected blood), especially from an infected child to an uninfected child during the first 5 years of life.
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