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FDA Delays ADHD Drug

August 3rd 2009

The U.S. Food and Drug Administration delayed the approval of Intuniv, an attention-deficit hyperactivity drug designed for children ages 6 to 17 years.
By Anelise Qumerais

The U.S. Food and Drug Administration delayed the approval of Intuniv, an attention-deficit hyperactivity drug designed for children ages 6 to 17 years, according to several reports.

After extensive labeling discussions, the FDA asked British-based Shire, Intuniv’s maker, for more information about the drug’s development.

The drugmaker, nonetheless, still expects final approval for Intuniv by year’s end.

"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, according to Reuters.

Shire specified that the FDA did not ask for new studies or issue safety concerns.

Shire also produces the popular ADHD drug Adderall.