November 27, 2002 WASHINGTON (AP) -- A new drug for the treatment of attention-deficit/hyperactivity disorder, the most commonly diagnosed behavioral disorder of childhood, was approved Tuesday by the Food and Drug Administration.
The drug is the first for ADHD that is not defined as a stimulant under certain federal laws, meaning it is exempt from some strict prescription rules. That allows patients to obtain the drug through phone-in refills and samples from physicians.
The drug's chemical name is atomoxetine HC1 and it will be marketed by Eli Lilly and Company of Indianapolis under the brand name Strattera.
It is approved for use by children, adolescents and adults for control of symptoms of ADHD, a condition that affects about 12 million Americans, including an estimated 8 million adults.
An estimated 3 percent to 7 percent of children have ADHD. Its symptoms include poor attention and concentration and low impulse control. Some studies have suggested the disorder can be inherited. It is estimated that up to 60 percent of children with ADHD continue to have symptoms as adults.
Atomoxetine HC1 has not been approved for use by children younger than 6. It also is not approved for use with monoamine oxidase inhibitor, an antidepressant, or in patients with narrow angle glaucoma.
In drug trials, some children and adolescents experienced side effects such as nausea, decreased appetite, vomiting, tiredness and upset stomach. Among adults, side effects included sleep problems, dry mouth, decreased appetite, upset stomach, nausea, dizziness and sexual disorders.
Strattera should be on sale in pharmacies in January, a Lilly statement said.
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