Tag: Lupin

U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

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U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for treatment of human immunodeficiency virus infection in…

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Lupin gets U.S. FDA nod for two generic diabetes drugs 

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Lupin gets U.S. FDA nod for two generic diabetes drugs 

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company’s injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen…

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