Alembic’ Aleor Dermaceuticals receives US FDA tentative approval for Diclofenac Sodium topical solution

Alembic Pharmaceuticals recently announced that its joint venture Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2 per cent w/w. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2 per cent w/w, of HZNP, Medicines LLC (HZNP). Diclofenac Sodium Topical Solution USP, 2 per cent w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Diclofenac Sodium Topical Solution USP, 2 per cent w/w, has an estimated market size of US$ 974
million for twelve months ending December 2018 according to IQVIA.

Alembic has a cumulative total of 109 ANDA approvals (96 final approvals and 13 tentative
approvals) from US FDA.