Aleor Dermaceuticals Limited receives USFDA Final Approval for Clobetasol Propionate Foam, 0.05%

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) 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 Inc. Clobetasol Propionate Foam is a corticosteroid indicated for 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$10 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 765.75 as compared to the previous close of Rs. 770.75. The total number of shares traded during the day was 16147 in over 1292 trades.

The stock hit an intraday high of Rs. 771.10 and intraday low of 759.05. The net turnover during the day was Rs. 12358990.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 AleorDermaceuticals FinalApproval ANDA USFDA ClobetasolPropionateFoam