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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:  04/24/2013
Trade Name:  Prezista
Generic Name or Proper Name (*):  darunavir
Indications Studied:  Treatment of HIV-1 infection
Label Changes Summary:  * Revised labeling to include pharmacokinetic, safety, tolerability, and virologic response data from a 48 week study for HIV-1 treatment experienced pediatric patients 3 to < 6 years * Additional information on adverse reactions * Postmarketing study
Product Labeling:  Labeling  Opens a new window
Sponsor:  Jannsen
Therapeutic Category:  Antiviral