Alembic Pharmaceuticals' JV gets USFDA final nod for anti-fungal drug

Alembic Pharmaceuticals Ltd on Tuesday said its joint venture, Aleor Dermaceuticals Ltd (Aleor), has received final approval from the US health regulator for its generic version of Nystatin and Triamcinolone Acetonide ointment used for the treatment of cutaneous candidiasis.

Cutaneous candidiasis is an infection of the skin and nails caused by the candida fungus.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment of strength 100,000 units/gram, Alembic Pharmaceuticals said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD) Nystatin and Triamcinolone Acetonide ointment of Taro Pharmaceuticals USA Inc, it added.

The company further said Nystatin and Triamcinolone Acetonide ointment 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.

Citing IQVIA data, Alembic said Nystatin and Triamcinolone Acetonide ointment has an estimated market size of USD 4 million for the 12-month period ending December 2021.