Mumbai, June 29: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Dapsone Gel, 5percentage.
The approved ANDA is therapeutically equivalent to the reference listed drug product , Aczone Gel, 5 percentage, of Almirall, LLC. Dapsone Gel is indicated for the topical treatment of acne vulgaris. Refer label for a detailed indication.
Alembic has a cumulative total of 244 ANDA approvals from USFDA.
