US FDA approves Lupin for generic drugs to treat HIV infection

Mumbai: Lupin, a transnational pharmaceutical company today announced that it had received tentative approval from the United States Food and Drug Administration (USFDA) to market its generic version of Dolutegravir and Rilpivirine tablets used in the treatment of HIV infection.

The tentative approval granted by the US regulator is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets, 50 mg/25 mg, to market a generic equivalent of Juluca Tablets, 50 mg/25 mg of ViiV Healthcare Company.

According to IQVIA MAT in September 2022, an estimated sale of USD 666 million was generated from Dolutegravir and Rilpivirine Tablets in the US.