Aurobindo Pharma receives USFDA Approval for Diclofenac Sodium Topical Solution USP

Aurobindo Pharma Limited has announced that its step-down subsidiary company, Aurolife Pharma LLC., has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC (Horizon). The product is expected to be launched in Q1FY24.

The approved product has an estimated market size of around US$ 487 million for the twelve months ending December 2022, according to IQVIA.

This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.

Diclofenac Sodium Topical Solution USP, 2% w/w is Indicated for the treatment of the pain of osteoarthritis of the knee(s).

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 418.65 as compared to the previous close of Rs. 415.45. The total number of shares traded during the day was 48541 in over 2163 trades.

The stock hit an intraday high of Rs. 421.40 and intraday low of 410.45. The net turnover during the day was Rs. 20177719.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 AurolifePharmaLLC FinalApproval USFDA DiclofenacSodiumTopicalSolution