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


  • Print
  • Share
  • E-mail

Alefacept Product Approval Information - Licensing Action 1/30/03

Proper name: Alefacept
Tradename: Amevive
Manufacturer: Biogen, Inc, Cambridge, MA, License #1204
Indication for Use: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy
Approval Date: 1/30/2003
Type of submission: Biologics license application


Label (PDF)

Clinical Pharmacology Review - (PDF)

Clinical Review - (PDF Part 2)

CMC Review - (PDF)

Pharmacology and Toxicology Review - (PDF)