Shire has received a Complete Response letter for INTUNIV (guanfacine) Extended Release from FDA. Reportedly, FDA did not identify safety concerns regarding INTUNIV in the letter about the new clinical studies.
Shire and FDA would continue to work together to resolve the remaining labeling language over the next four to eight weeks, said the company.
Mike Cola, president of Shire, said: “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. 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.”