Aurobindo Pharma announced that its step-down subsidiary company, Aurolife Pharma LLC., has received final FDA approval to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to Horizon Therapeutics Ireland DAC’s reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w (Horizon). The product is scheduled 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 approved from the Aurolife Unit-II in North Carolina, USA, which is used to manufacture topical products. Aurobindo now has 430 ANDA approvals from the USFDA (404 final approvals and 26 tentative approvals). Diclofenac Sodium Topical Solution USP, 2% w/w is indicated for the relief of knee osteoarthritis pain (s).