Aurobindo Pharma on Tuesday said step-down subsidiary Aurolife Pharma LLC has received the final approval from U.S. Food and Drug Administration to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is indicated for treatment of pain from osteoarthritis of the knee.
This is the first ANDA (abbreviated new drug application) to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. The product is expected to be unveiled in the first quarter of FY24, the company said.
The approved product, which is bioequivalent and therapeutically equivalent to Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC, has an estimated market size of about $487 million for the 12 months ending December 2022, Aurobindo Pharma said, citing IQVIA numbers.
Aurobindo said it now has a total of 430 ANDA approvals (404 final approvals and 26 tentative approvals) from the U.S. FDA.
