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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:  10/26/2013
Trade Name:  Sabril
Generic Name or Proper Name (*):  vigabatrin
Indications Studied:  Refractory complex partial seizures (rCPS)
Label Changes Summary:  *Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS * Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established *Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight *Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia *Information on weight based dosing, dosing in renal impairment, safety information and clinical trials
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B,P
Sponsor:  Lundbeck LLC
Pediatric Exclusivity Granted Date:  10/03/2013
Therapeutic Category:  Anticonvulsant