Lupin gets tentative USFDA approval for Dolutegravir, Rilpivirine tablets

The drug major said that it has received tentative approval from United States Food and Drug Administration (USFDA) to market its abbreviated new drug application (ANDA), Dolutegravir and Rilpivirine tablets, 50 mg/25 mg.

The approved ANDA is generic of Juluca tablets, 50 mg/25 mg of ViiV Healthcare Company.

Dolutegravir and Rilpivirine helps to decrease the amount of HIV in the blood and increase the number of immune cells that help to fight infections in your body.

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

Separately Lupin said that USFDA inspected the company's Somerset, New Jersey, U.S.A. manufacturing facility from 2 January to 13 January 2023 and issued a form-483 with two observations.

"We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance and are committed to be compliant with CGMP standards across all our facilities," the drug major said.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

On consolidated basis the company reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4091.16 crore in Q2 FY23 as compared to Rs 4003.42 crore in Q2 FY22.

The scrip was down 0.24% to Rs 753.75 on the BSE.

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