Aurobindo Pharma’s, Aurolife Pharma LLC., has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of osteoarthritis.
The product is expected to be launched in Q1 FY24. The approved product has an estimated market size of around $487 million for the twelve months ending December 2022, according to IQVIA.
“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,” Hyderabad-based Aurobindo said in a release on Wednesday. Aurobindo now has a total of 430 ANDA approvals (404 final and 26 tentative approvals) from USFDA.
Aurobindo Pharma’s script gained 6.32 per cent on the Bombay Stock Exchange on Wednesday to end at ₹445.10.