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Alembic Pharma gets US regulator final nod for skin ointment - Desonide Cream
New Delhi: Alembic Pharmaceuticals (Alembic) on Friday announced that it received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) -- Desonide Cream, 0.05 per cent, an ointment used for the treatment of skin conditions.
According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis US LLC. Desonide Cream, 0.05 per cent, is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Desonide Cream, 0.05 per cent, has an estimated market size of USD 12 million for twelve months ending September 2022, according to pharma firm IQVIA.
Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
An abbreviated new drug application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.
According to the statement, Alembic Pharmaceuticals, a vertically integrated research and development (R-D) pharmaceutical company, has been at the forefront of health care since 1907.
Alembic is a publicly-listed company that manufactures and markets generic pharmaceutical products across the world. Alembic's latest R-D facilities are approved by regulatory authorities of many developed countries, including the USFDA. (ANI)