Aurobindo Pharma bags USFDA nod for HIV drug Darunavir

Hyderabad: Aurobindo Pharma Limited has announced that the Company 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.

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.

The product will be launched on November 29, 2023.

Medical Dialogues team had earlier reported that Aurobindo had received USFDA tentative approval under the PEPFAR program for the first generic dispersible tablet formulation of the fixed dose combination Abacavir 60mg + Lamivudine 30 mg + Dolutegravir 5 mg (pALD), for the treatment of children living with HIV weighing 6 kg to <25 kg and aged at least 3 months.

Read also: USFDA tentative nod to Aurobindo Pharma's generic FDC drug to treat HIV in children

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.

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