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