Lupin gets tentative approval from USFDA for Dolutegravir Tablets

04 Jul 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg, to market a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company. 

This product will be manufactured at Lupin’s Nagpur facility in India. Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD) had estimated annual sales of $1 million in the U.S. (IQVIA MAT March 2023). 

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.

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