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.
