Alembic Pharma bags USFDA final approval for Desonide Cream

  • India Infoline News Service |
  • 09 Dec, 2022 |
  • 1:07 PM
Alembic Pharmaceuticals
Alembic Pharmaceuticals Limited (Alembic) has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%.

The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05%, of Padagis US LLC.

Desonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses. Refer to our label for full indication.

Desonide Cream, 0.05%, has an estimated market size of US$12 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.

At around 1:08 PM, Alembic Pharmaceuticals Ltd is currently trading at Rs594.10 per share down by Rs5.1 or 0.85% from its previous closing of Rs599.20 per share on the BSE.

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