Alembic Pharmaceuticals Limited has received one US Food & Drug Administration (USFDA) Product Approval (Tentative) during the quarter ended 31st March, 2024. Alembic has a cumulative total of 197 ANDA approvals (170 final approvals and 27 tentative approvals) from USFDA. Product Name Ribociclib Tablets, 200 mg.

Approval Final/Tentative, Innovator Novartis Pharmaceuticals Corporation, Brand name Kisqali Tablets. Ribociclib tablet indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy.