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Oforta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (Discontinued) (First approved December 18, 2008)
Brand name: Oforta
Generic name: fludarabine phosphate
Dosage form: Tablets
Company: Sanofi
Treatment for: Chronic Lymphocytic Leukemia

Marketing Status: Discontinued

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 timeline 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

See also

Oforta (fludarabine phosphate) Consumer information

Further information

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