Tuesday , October 19 2021

Alembic Pharma’s JV gets USFDA’s nod for Desonide Ointment

Alembic Pharmaceuticals’ joint venture (JV) Aleor Dermaceuticals (Aleor) has received approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Desonide Ointment, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Ointment, 0.05%, of Perrigo New York, Inc. Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Desonide Ointment, 0.05%, has an estimated market size of $13 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 105 ANDA approvals (93 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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