A significant milestone has been achieved by Aurobindo Pharma as it receives approval from the US Food and Drug Administration (USFDA) to market a generic medication for treating human immunodeficiency virus (HIV-1) infection.

The Hyderabad-based pharmaceutical company disclosed this development in a regulatory filing on Wednesday.

The approval encompasses the manufacture and marketing of Darunavir tablets in strengths of 600 mg and 800 mg. Aurobindo Pharma's product is deemed therapeutically equivalent to the reference listed drug (RLD), Prezista tablets (600 mg and 800 mg) developed by Janssen Products, LP.

The drug firm announced the imminent launch of Darunavir tablets on the same day of receiving the regulatory approval.

The newly approved medication, Darunavir tablets in 600 mg and 800 mg strengths, when used alongside other antiretroviral agents, is specifically indicated for treating HIV-1 infection in both adult and pediatric patients aged 3 years and above.

According to IQVIA data, the estimated market size for the approved product stands at a substantial USD 274.8 million, covering the 12 months leading up to October 2023.

Aurobindo Pharma highlighted this approval as a significant addition, marking a total of 500 Abbreviated New Drug Application (ANDA) approvals obtained from the USFDA.

This latest nod from the USFDA underlines Aurobindo Pharma's commitment to enhancing its portfolio of medications catering to critical therapeutic areas and its mission to provide accessible, high-quality generic medications to patients in need.