USFDA gives nod for Diclofenac Sodium Topical Gel

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze topical gel, 3%, of Fougera Pharmaceuticals Inc. (Fougera).

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USFDA
Picture: Pixabay

Last Updated on August 1, 2022 by The Health Master

Alembic Pharmaceuticals Limited (Alembic) 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%.

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 March 2022 according to IQVIA. Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

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