Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram.

Tuesday April 13, 2021 at 2:21 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 Cream USP, 100,000 units/gram and 1 mg/gram. 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. Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatinsteroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. Nystatin and Triamcinolone Acetonide Cream, USP has an estimated market size of US$ 19 million for twelve months ending December 2020 according to IQVIA. Alembic has a cumulative total of 139 ANDA approvals (123 final approvals and 16 tentative approvals) from USFDA.

Releted Blog
  • Benefits of High-Intensity Interval Training workout

    In the realm of fitness, High-Intensity Interval Training (HIIT) has emerged as a revolutionary approach to exercise. This intense yet time-efficient ...

  • Everything Around Mental Wellness

    Introduction In today's fast-paced and demanding world, mental health has emerged as a critical aspect of overall well-being. The stigma surrounding ...

  • Health Benefits of Resistance Training

    In the pursuit of a healthier and more fulfilling life, exercise plays a pivotal role. Among the diverse forms of exercise, resistance training stands...