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Besponsa FDA Approval History

FDA Approved: Yes (First approved August 17, 2017)
Brand name: Besponsa
Generic name: inotuzumab ozogamicin
Dosage form: for Injection
Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Development Timeline for Besponsa

DateArticle
Aug 17, 2017Approval FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
Feb 21, 2017Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration

Further information

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