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Oforta Approval History

  • FDA approved: Yes (First approved December 18th, 2008)
  • Brand name: Oforta
  • Generic name: fludarabine phosphate
  • Dosage form: Tablets
  • Previous name: Oral Fludarabine
  • Company: sanofi-aventis U.S.
  • Treatment for: Chronic Lymphocytic Leukemia

Oforta (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).

Development History and FDA Approval Process for Oforta

DateArticle
Dec 19, 2008Approval Antisoma Receives FDA Approval for Oral Fludarabine, Plans Commercialization Deal to Bring Drug to US Patients
Jan 22, 2008Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA

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