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 $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.