Aleor Dermaceuticals receives USFDA Final Approval for Docosanol Cream, 10% (OTC)

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 Docosanol Cream, 10% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Abreva Cream, 10% (OTC), of GlaxoSmithKline Consumer Healthcare. Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips.

Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA.

Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 786.80 as compared to the previous close of Rs. 781.50. The total number of shares traded during the day was 14887 in over 953 trades.

The stock hit an intraday high of Rs. 790.00 and intraday low of 761.00. The net turnover during the day was Rs. 11656961.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 AleorDermaceuticals FinalApproval USFDA ANDA DocosanolCream