Alembic Pharmaceuticals on Friday said it has received approval from the U.S. health regulator to market Desonide Cream used in treating skin conditions with inflammation and itching in the American market.
The company said it has received the final approval from the U.S. Food and Drug Administration for its abbreviated new drug application Desonide Cream, 0.05%.
The ANDA was filed by Aleor Dermaceuticals, which was amalgamated with Alembic, the drug firm said in a statement.
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.
According to IQVIA, Desonide Cream, 0.05%, has an estimated market size of $12 million for twelve months ending September 2022.
Alembic said it has now received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from the U.S. FDA.
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