Denileukin diftitox
Product Approval Information - Licensing Action
Proper name: Denileukin diftitox
Tradename: Ontak
Manufacturer: Seragen, Inc, Hopkinton, MA, License #1258
Indication for Use: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor
Approval Date: 2/5/99
Type of submission: Biologics license application
Approval Letter (PDF),
(Text)
Label (PDF)
SBA (PDF)
Reviews
Talk Paper
Last Updated: 12/19/2001
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Updated: September 25, 2003 |