Aleor Dermaceuticals gets USFDA final approval for Diclofenac Sodium Topical Gel, 3%

29 Jul 2022 , 03:00 PM

Alembic Pharmaceuticals Limited 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 ANDA (Abbreviated New Drug Application)for Diclofenac Sodium Topical Gel, 3%.

As per the  filing, 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 for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy.

According to IQVIA, Diclofenac Sodium Topical Gel, 3% has an estimated market size of. US$10 million for twelve months ending March, 2022.

As for now, Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

At around 3:00 PM, Alembic Pharmaceuticals was trading at Rs704.35 per share up by Rs3.2 or 0.46% from its previous closing of Rs701.15 per share on the BSE.

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