The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing.
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Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection.
The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) 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 USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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First Published: Tue, January 17 2023. 00:14 IST
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