Lupin gets tentative US FDA approval for Dolutegravir Tablets for Oral Suspension

Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) 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 US. (IQVIA MAT March 2023).