Express Pharma

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

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis

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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.

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