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).