Alembic Pharmaceuticals on Thursday said it has received final approval from the U.S. health regulator for its generic version of diclofenac sodium topical solution indicated to treat pain of osteoarthritis of the knee.
The approval by the U.S. Food & Drug Administration for the abbreviated new drug application of diclofenac sodium topical solution is for strength of 2%, the company said in a statement.
"The ANDA was filed by Aleor Dermaceuticals (Aleor), which was amalgamated with Alembic," it added. Aleor had previously received a tentative approval for this ANDA.
The approved ANDA is therapeutically equivalent to the reference listed drug product Pennsaid topical solution, 2% of Horizon Therapeutics Ireland DAC (Horizon), Alembic said.
As per IQVIA data, the company said the diclofenac sodium topical solution, 2% had an estimated market size of $512 million for 12 months ended September 2022.
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