Aurobindo Pharma Ltd’s shares were up by 0.50 per cent following the company’s announcement of receiving final approval from the US Food & Drug Administration (USFDA) for Darunavir tablets, 600 mg and 800 mg. The approved product, which is bioequivalent to Janssen’s Prezista tablets, is set to launch on November 29, 2023, with an estimated market size of $274.8 million.
Aurobindo achieved a total of 500 ANDA approvals from the USFDA, including 478 Final approvals and 22 tentative approvals. Darunavir tablets are indicated for the treatment of HIV-1 infection in patients aged three years and older.
The shares were up by 0.50 per cent to ₹1,022.65 at 12 pm on the BSE.