Alembic Pharma receives USFDA final approval for Diclofenac Sodium Topical Solution

2 Dec 2022 , 09:19 AM

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w.

The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US$512 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 177 ANDA approvals (154 final approvals and 23 tentative approvals) from USFDA.

At around 9:18 AM, Alembic Pharmaceuticals Ltd is currently trading at Rs598.15 per share up by Rs4.5 or 0.76% from its previous closing of Rs593.65 per share on the BSE.

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