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8th March 2022, Mumbai: 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.
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