Alembic receives USFDA approval for Diclofenac Sodium Topical Solution

Alembic Pharmaceuticals 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 (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.

 

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