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Sprycel FDA Approval History

FDA Approved: Yes (First approved June 28, 2006)
Brand name: Sprycel
Generic name: dasatinib
Dosage form: Tablets
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Development Timeline for Sprycel

Jan  2, 2019Approval Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Nov 10, 2017Approval FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
Jun 21, 2013Approval FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase
Oct 28, 2010Approval FDA approves additional medical indication for Sprycel
May 26, 2009Approval FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec
Nov  9, 2007Approval FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Jun 28, 2006Approval Sprycel Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)
Jun  2, 2006Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib
Mar  7, 2006FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
Dec 28, 2005Bristol-Myers Squibb Submits New Drug Application for Dasatinib

Further information

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