Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. ANDA 216547, held by Eugia Pharma. Dasatinib.
As of Nov 15, 2026, ANDA 216547 (Dasatinib), held by Eugia Pharma, was first approved by FDA on Apr 22, 2025, with 0 approved supplements and 0 published complete response letters.
Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2025 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
