The US Food and Drug Administration (USFDA) has granted final approval to Aurobindo Pharma’s Aurolife Pharma LLC. to manufacture and market Diclofenac Sodium Topical Solution. The approved product is bioequivalent and therapeutically equivalent to Horizon Therapeutics Ireland DAC’s reference listed drug (RLD), Pennsaid Topical Solution (Horizon). Diclofenac Sodium Topical Solution is prescribed to treat osteoarthritis.
The product is expected to be released in the first quarter of fiscal year 24. According to IQVIA, the approved product has a market size of around $487 million for the twelve months ending December 2022.”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,” Aurobindo, based in Hyderabad, said in a statement on Wednesday. Aurobindo now has 430 ANDA approvals from the USFDA (404 final and 26 tentative).