US FDA gives final approval to Alembic Pharma’s Desonide cream

The US Food and Drug Administration (FDA) has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%. The ANDA was filed by Aleor Dermaceuticals, which was amalgamated with Alembic, according to a statement from Alembic Pharma.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis. Desonide cream, 0.05% is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, the statement said.