Alembic Pharmaceuticals receives USFDA Final Approval for Desonide Cream, 0.05%

Alembic Pharmaceuticals Limited (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, 0.05%. 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. Refer to our label for full indication.

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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 599.20 as compared to the previous close of Rs. 588.10. The total number of shares traded during the day was 2937 in over 339 trades.

The stock hit an intraday high of Rs. 601.00 and intraday low of 590.25. The net turnover during the day was Rs. 1752757.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA ANDA FinalApproval DesonideCream