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Aleor s ANDA for treatment of cutaneous candidiasis gets USFDA nod

Aleor’s ANDA for treatment of cutaneous candidiasis gets USFDA nod April 01, 2021 ANDA is for Nystatin and Triamcinolone Acetonide Cream USP to be marketed in US Alembic Pharmaceuticals Limited’s joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US drug regulator, US Food & Drug Administration (USFDA), for an Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, the company informed. Aleor is a 60:40 joint venture between Alembic Pharmaceuticals Limited and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) focused on commercialising dermatology products globally. 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, an official statement said here.

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