• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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)

SBA (PDF)

Reviews

 

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