Aleor Dermaceuticals receives USFDA Final Approval for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram

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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 710.75 as compared to the previous close of Rs. 712.10. The total number of shares traded during the day was 5175 in over 582 trades.

The stock hit an intraday high of Rs. 714.85 and intraday low of 696.05. The net turnover during the day was Rs. 3658416.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 AleorDermaceuticals ANDA Approval USFDA Nystatin TriamcinoloneAcetonide