Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. ANDA 217217, held by Biocon Pharma. Dasatinib.
As of Nov 14, 2026, ANDA 217217 (Dasatinib), held by Biocon Pharma, was first approved by FDA on Mar 3, 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 |
|---|---|---|---|
| Mar 3, 2025 | Original application | Approved |
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
