PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP,
NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces
that it has received a Complete Response letter today for INTUNIV(TM)
(guanfacine) Extended Release from the Food and Drug Administration (FDA).
This decision comes following labeling discussions with the FDA that did not
result in agreement in time to meet the PDUFA date.
The FDA did not identify safety concerns regarding INTUNIV in the
Complete Response letter or request new clinical studies. Shire and the FDA
will continue to work together to resolve the remaining labeling language
over the next 4 to 8 weeks.
'Shire is confident that we will quickly come to agreement on the final
product label and anticipates a launch in the fourth quarter as planned,'
said Mike Cola, President of Shire Specialty Pharmaceuticals. 'When approved,
INTUNIV will be the first selective alpha-2A receptor agonist for the
treatment of ADHD, and will provide patients with an important new treatment
option.'
About INTUNIV
INTUNIV is being studied for the treatment of ADHD in children and
adolescents aged 6 to 17 years. INTUNIV is a once-daily, extended release
formulation of guanfacine, designed to provide steady delivery of drug
throughout the day.
