The US Food and Drug Administration (FDA) has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w, a statement from Alembic Pharma said.
The ANDA filed by Aleor Derma was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC (Horizon), the statement added.
Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knees, concluded the statement.