Alembic Pharmaceuticals receives USFDA approval for Diclofenac Sodium Topical Gel, 3%

Used for topical treatment of actinic keratoses

Alembic Pharmaceuticals today announced that its 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. US$10 million for twelve months ending Mar., 2022 according to IQVIA.

 

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