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U.S. Department of Health and Human Services


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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)

Label (PDF)




Clinical - (PDF)  Part C
Clinical Pharmacology (PDF)
Pharmacology (PDF)
Statistical (PDF)