Pharmaceutical firm Lupin on Monday said it has received tentative approval from the U.S. health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection.
The tentative approval granted by the U.S. Food and Drug Administration is for the abbreviated new drug application of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing.
The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of $666 million in the U.S., the company said citing IQVIA MAT September 2022 data.
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