Global pharma major Lupin Limited on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.
According to the company’s press statement, it is the generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company.
Dolutegravir is an antiretroviral medication used, together with other medications, to treat HIV/AIDS.
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).
