Aleor Dermaceuticals receives USFDA approval for Clobestasol

Aleor Dermaceuticals receives USFDA approval for Clobestasol

By: IPP Bureau

Last updated : April 25, 2022 11:36 am



Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA


Alembic Pharmaceuticals announced that its wholly-owned subsidiary, Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for  Clobetasol Propionate Foam, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Olux Foam, 0.05%, of Mylan Pharmaceuticals.

Clobetasol Propionate Foam is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.

Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA.

Alembic has received a cumulative total of 165 ANDA approvals (141 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals Aleor Dermaceuticals ANDA USFDA

First Published : April 25, 2022 12:00 am