Drugmaker Aurobindo Pharma has obtained U.S. Food and Drug Administration remaining approval to fabricate and market Darunavir Tablets 600 mg and 800 mg.
The accepted product is bioequivalent and therapeutically equal to the reference listed drug Prezista Tablets 600 mg and 800 mg of Janssen Products LP, Aurobindo stated on November 29.
In mixture with different antiretroviral brokers, Darunavir Tablets 600 mg and 800 mg are indicated for therapy of human immunodeficiency virus (HIV-1) an infection in grownup and paediatric sufferers 3 years of age and older.
The accepted product has an estimated market measurement of $274.8 million for the twelve months ending October 2023, Aurobindo stated citing IQVIA numbers. The firm stated it has 500 ANDA approvals (478 remaining approvals and 22 tentative approvals) from U.S. FDA.
