Aurobindo Pharma receives USFDA Approval for Fingolimod Capsules, 0.5 mg

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fingolimod Capsules, 0.5 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation. The product will be launched in March 2024.

The approved product has an estimated market size of US$ 447.3 million for the twelve months ending January 2024, according to IQVIA. Aurobindo now has a total of 505 ANDA approvals (486 Final approvals and 19 tentative approvals) from USFDA.

Fingolimod Capsules, 0.5 mg, is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1026.50 as compared to the previous close of Rs. 1027.45. The total number of shares traded during the day was 35347 in over 1708 trades.

The stock hit an intraday high of Rs. 1031.50 and intraday low of 1012.00. The net turnover during the day was Rs. 36167284.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 USFDA Approval FingolimodCapsules