INTUNIV(TM) - for the treatment of ADHD in children and adolescents in the US.
- On May 19, 2009 Shire announced that a randomized placebo controlled trial had met its primary objective, evaluating the effects of INTUNIV on oppositional symptoms in children aged 6 to 12 years with a diagnosis of ADHD and the presence of oppositional symptoms. - The Prescription Drug User Fee Act date ("PDUFA") for INTUNIV was July 27, 2009. Shire has received a Complete Response Letter from the FDA for INTUNIV. Shire and the FDA were not able to reach agreement on final product labeling in time to meet the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV, request new clinical data or additional analyses in the Complete Response Letter. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4-8 weeks and we anticipate launch in the fourth quarter of 2009 as planned. VYVANSE - for the treatment of non ADHD indications in adults - Shire is conducting Phase 2 pilot cli
|SOURCE Shire Plc|
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