Alembic Pharma JV 'Aleor' receives USFDA nod for Nystatin and Triamcinolone Acetonide Ointment

8 Mar 2022 , 12:45 PM

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 Ointment USP, 100,000 units/gram.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1 %, of Taro Pharmaceuticals U.S.A. Inc. 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.

Nystatin and Triamcinolone Acetonide Ointment has an estimated market size of US$4 million for twelve months ending Dec 2021 according to IQVIA.

Alembic has received year-to-date (YTD) 21 approvals (15 final approvals and 6 tentative approvals) and· a cumulative total of 160 ANDA approvals (138 final approvals and 22 tentative approvals) from USFDA.

At around 12.45 pm, Alembic Pharmaceuticals Ltd was trading flat at Rs710.75 per piece on the BSE.