Aurobindo Pharma it has received approval from the US health regulator to market a generic medication for the treatment of human immunodeficiency virus (HIV-1) infection.

• The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Darunavir tablets in strengths of 600 mg and 800 mg, the Hyderabad-based drug maker said in a regulatory filing.
• The company’s product is therapeutically equivalent to the reference listed drug (RLD), Prezista tablets, 600 mg and 800 mg, of Janssen products, LP, it added.
• Darunavir tablets, 600 mg and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.
• As per IQVIA data, the approved product has an estimated market size of USD 274.8 million for the 12 months ended October 2023.
• Aurobindo noted that it now has a total of 500 Abbreviated New Drug Application (ANDA) approvals from the USFDA.