Aurobindo Pharma Receives USFDA Approval For Darunavir Tablets

Aurobindo Pharma Limited on Wednesday announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, L.P., the company announced through an exchange filing.

The product will be launched on November 29, 2023.

The approved product has an estimated market size of US dollar 274.8 million for the twelve months ending October 2023, according to IQVIA. Aurobindo now has a total of 500 ANDA approvals (478 Final approvals and 22 tentative approvals) from USFDA.

Darunavir Tablets, 600 mg and 800 mg, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients 3 years of age and older.

Aurobindo Pharma Limited shares

The shares of Aurobindo Pharma Limited on Wednesday at 12:02 pm IST were at Rs 1,021.80, up by 0.56 percent.