Alembic Pharmaceuticals introduced that its fully owned subsidiary, Aleor Dermaceuticals Ltd (Aleor) has acquired very last approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, three%.The authorised ANDA is therapeutically equal 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 at some point of therapy.
Diclofenac Sodium Topical Gel, 3% has an expected marketplace size of. US$10 million for 12 months finishing Mar., 2022 in step with IQVIA.
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