Alembic Pharmaceuticals’ arm gets USFDA’s nod for Diclofenac Sodium Topical Gel

29 Jul 2022 Evaluate

Alembic Pharmaceuticals’ wholly owned subsidiary -- Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.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. $10 million for twelve months ending March, 2022 according to IQVIA. Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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