Alembic Pharmaceuticals Limited on Friday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%.
According to the pharma major, the ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic.
“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,” the company stated on Friday.
The cream is indicated for atopic dermatitis, seborrheic dermatitis, contact dermatitis and psoriasis in both adults and children.
Desonide Cream, 0.05%, has an estimated market size of US$12 million for twelve months ending Sep 2022 according to IQVIA. Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.