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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  09/29/2006
Trade Name:  Fuzeon
Generic Name or Proper Name (*):  enfuvirtide
Indications Studied:  HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
Label Changes Summary:  * Additional safety and efficacy data and AE information from clinical study in 5-16 year olds * Insufficient data to provide dosing recommendations in patients < 6 years
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Hoffmann-La Roche
Therapeutic Category:  Antiviral