Aleor gets USFDA nod for drug for cutaneous candidiasis treatment

Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis

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Approved
Picture: Pixabay

Last Updated on April 3, 2021 by The Health Master

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals 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 USA.

USFDA
Picture: Pixabay

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.

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Nystatin and Triamcinolone Acetonide Cream, USP has an estimated market size of $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.


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