Alembic Pharmaceuticals receives USFDA tentative approval for Ribociclib Tablets

Alembic Pharmaceuticals has received US Food & Drug administration (USFDA) Product Approval (Tentative) for Ribociclib Tablets, 200 mg.

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.

Alembic has a cumulative total of 197 ANDA approvals (170 final approvals and 27 tentative approvals) from USFDA.

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