By: IPP Bureau
Last updated : November 29, 2023 1:35 pm
Aurobindo Pharma Limited 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 product will be launched on November 29, 2023.
The approved product has an estimated market size of US$ 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.