Alembic Pharmaceuticals receives USFDA approval for Desonide Cream

10 Dec 2022 , 12:01 PM

Alembic Pharmaceuticals Alembic today announced that it has received final approval from the US Food Drug Administration USFDA for its Abbreviated New Drug Application ANDA Desonide Cream 005Percentage 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 005Percentage of Padagis US LLC Desonide Cream 005Percentage is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses Refer to our label for full indication Desonide Cream 005Percentage 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