Aurobindo Pharma subsidiary gets USFDA approval to market Diclofenac Sodium Topical Solution

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.

The Diclofenac Sodium Topical Solution USP, 2% w/w, 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 company said.

Further, 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. 

The Company 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 knees.