Aurobindo Pharma receives USFDA approval for Diclofenac Sodium Topical Solution USP

Aurobindo Pharma 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).

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