Aleor Dermaceuticals receives USFDA Final Approval for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram

Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

Nystatin and Triamcinolone Acetonide Cream, USP has an estimated market size of US$ 19 million for twelve months ending December 2020 according to IQVIA.

Alembic has a cumulative total of 139 ANDA approvals (123 final approvals and 16 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.960 as compared to the previous close of Rs. 956.65. The total number of shares traded during the day was 14297 in over 1566 trades.

The stock hit an intraday high of Rs. 969.15 and intraday low of 949.9. The net turnover during the day was Rs. 13749601.

Source : Equity Bulls

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