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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:  08/28/2019
Trade Name:  Harvoni Oral Pellets
Generic Name or Proper Name (*):  ledipasvir and sofosbuvir
Indications Studied:  Treatment of chronic hepatitis C virus
Label Changes Summary:  *Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial. *New dosage form.
BPCA(B) and PREA(P):  B,P
Sponsor:  Gilead Sciences, Inc.
Pediatric Exclusivity Granted Date:  07/23/2019
Therapeutic Category:  Antiviral