Alembic Pharmaceuticals announced that its joint venture Aleor
Dermaceuticals has received final approval from the US Food & Drug
Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desonide Lotion, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), DesOwen Lotion, 0.05% of Galderma Laboratories LP. Desonide Lotion is low to medium potency corticosteroids indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Desonide Lotion, 0.05% has an estimated market size of US$ 7 million for twelve months ending June 2020 according to IQVIA.
Alembic has a cumulative total of 129 ANDA approvals (113 final approvals and 16 tentative approvals) from USFDA.
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