Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic version of diclofenac sodium topical solution indicated to treat pain of osteoarthritis of the knee.
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of diclofenac sodium topical solution is for strength of 2 per cent, 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 per cent of Horizon Therapeutics Ireland DAC (Horizon), Alembic said.
As per IQVIA data, the company said the diclofenac sodium topical solution, 2 per cent had an estimated market size of USD 512 million for 12 months ended September 2022.
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