Alembic Pharmaceuticals obtained 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 became filed by means of Aleor Dermaceuticals (Aleor) which became amalgamated with Alembic. The authorised ANDA is therapeutically equal 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). Refer to our label for complete indication. Aleor had previously obtained tentative popularity of this ANDA.
Diclofenac Sodium Topical Solution USP, 2% w/w has an anticipated market size of US$512 million for three hundred and sixty five days ending Sep 2022 in line with IQVIA.
Alembic has acquired a cumulative total of 177 ANDA approvals from USFDA.
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