Drugmaker Aurobindo Pharma has received U.S. Food and Drug Administration final approval to manufacture and market Darunavir Tablets 600 mg and 800 mg.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Prezista Tablets 600 mg and 800 mg of Janssen Products LP, Aurobindo said on November 29.
In combination with other antiretroviral agents, Darunavir Tablets 600 mg and 800 mg are indicated for treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients 3 years of age and older.
The approved product has an estimated market size of $274.8 million for the twelve months ending October 2023, Aurobindo said citing IQVIA numbers. The company said it has 500 ANDA approvals (478 final approvals and 22 tentative approvals) from U.S. FDA.