Lupin receives USFDA tentative approval for Dolutegravir and Rilpivirine Tablets

Lupin today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, to market a generic equivalent of Juluca Tablets, 50 mg/25 mg of ViiV Healthcare Company.

Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of USD 666 million in the U.S. (IQVIA MAT September 2022).

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