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FDA issues approvable letter for Strattera for ADHD

August 14, 2002 -- Eli Lilly and Company has received an approvable letter from the FDA for Strattera (atomoxetine hydrochloride), a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.

Approval is contingent upon labeling discussions, and submission of additional data or analyses from either existing studies or a potential new study. While Lilly continues to plan for final FDA approval in the spring of 2003, approval timing is contingent upon further discussions with the FDA regarding the additional data requested.

"We are delighted to reach this important milestone in the development of Strattera, and we are working closely with the FDA to complete this process as quickly as possible," said John Lechleiter, executive vice president of pharmaceutical products and corporate development at Eli Lilly and Company. "We're eager to bring this new treatment option to patients, families and health care professionals."

Lilly submitted its New Drug Application (NDA) for Strattera in October 2001. It included data from six placebo-controlled studies, involving children, adolescents and adults. So far, more than 4,000 patients have taken Strattera in clinical trials. ADHD affects 3-7 percent of school age children and manifests itself in levels of attention, concentration, activity, distractibility, and impulsivity that are inappropriate to the child's age group. Experts estimate 60 percent of children with the disorder carry their symptoms into adulthood.

Posted: August 2002