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MayDacogen™ (decitabine) for Injection was approved by the FDA on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo, and secondary MDS of all FAB subtypes (RA, RARS, RAEB, RAEB-t, CMML) and Intermediate-1, Intermediate-2, and High Risk IPSS groups. |
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AprilThe New Drug Application (NDA) for Saforis™ (glutamine in UpTec™) Powder for Oral Suspension is submitted to the U.S. Food and Drug Administration (FDA). A Prescription Drug User Fee Act (PDUFA) date of October 12, 2006 is later established. |
