Alembic Pharmaceuticals Limited (Alembic) on Friday announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.
According to the company’s press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, 3%, of Fougera Pharmaceuticals Inc. (Fougera).
Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy. Diclofenac Sodium Topical Gel, 3% has an estimated market size of US$10 million for twelve months ending Mar., 2022 according to IQVIA, the pharma company claims.
Meanwhile, the company also stated that Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.