Denileukin diftitox

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

Clinical - (PDF)  Part A, Part B, Part C
Clinical Pharmacology (PDF)
CMC (PDF)
Pharmacology (PDF)
Statistical (PDF)

Talk Paper

Last Updated: 12/19/2001

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Updated: September 25, 2003

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