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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)