Alembic Pharmaceuticals gets FDA final approval for Desonide Cream, 0.05%


Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) of Desonide Cream, 0.05% from the US Food and Drug Administration (FDA).

The ANDA for the generic version of Padagis US’ Desonide Cream, 0.05% was filed by Aleor Dermaceuticals, which was merged with Alembic Pharmaceuticals.

The approved product is a low potency corticosteroid to be used for relieving inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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According to IQVIA, Desonide Cream, 0.05% has an estimated market size of $12 million for 12 months ending September 2022.

Alembic Pharmaceuticals, which is an India-based company, has so far bagged 178 ANDA approvals from the FDA, of which 155 are final approvals and the rest are tentative approvals.

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