usfda: Aurobindo Pharma gets USFDA nod for HIV drug

Aurobindo Pharma on Wednesday said 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.

The product will be launched on Wednesday, the drug firm said.

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.

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