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Alefacept
Product Approval Information - Licensing Action
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
Approval Letter
(Text)
Label
(PDF),
(Text)
Clinical Pharmacology Review -
(PDF)
Clinical Review -
(PDF Part 1),
(PDF Part 2)
CMC Review -
(PDF)
Pharmacology and Toxicology Review -
(PDF)
Talkaper
FDA Approves First Biologic Therapy for Psoriasis
Last Updated: 6/27/2003
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Date created: September 16, 2003 |
