USFDA gives final approval for 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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USFDA Approval
USFDA Approval

Last Updated on October 10, 2024 by The Health Master

The US Food and Drug Administration (USFDA) 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 merged 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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