Lupin Dolutegravir Tablets for Oral Suspension gets tentative USFDA nod for HIV/AIDS
Mumbai: Global pharma major Lupin Limited today 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.
The product is a 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, for the treatment of 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 USD 1 million in the U.S. (IQVIA MAT March 2023).
Read also: Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray
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