First generic Strattera for ADHD approved

FDA has approved the first generic versions of Strattera (atomoxetine) for the treatment of attention deficit/hyperactivity disorder (ADHD).

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According to the Diagnostic and Statistical Manual of Mental Disorders- 5^th edition (DSM-5), ADHD is defined as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.

Atomoxetine is a selective norepinephrine re-uptake inhibitor originally approved in November 2002 under the brand name Strattera (Eli Lilly and Company) for treating ADHD. It is taken as an oral capsule as either a single daily dose or 2 evenly divided doses in the morning and evening.

Several drug makers, Apotex Inc., Teva Pharmaceuticals USA Inc, Aurobindo Pharma Limited and Glenmark Pharmaceuticals, can now market the medication in multiple strengths, including 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 110 mg.

Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. In addition, generic drugs approved by FDA have the same high quality and strength as the brand-name drugs.

“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

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Common adverse events associated with the use of atomoxetine in clinical trials for atomoxetine in children and adolescents included upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. Adults using atomoxetine reported in clinical trials that the most common side effects included constipation, dry mouth, nausea, decreased appetite, sexual side effects, and trouble passing urine.

Atomoxetine must be dispensed with a Medication Guide that describes the drug’s uses, side effects and warnings. Atomoxetine also has a boxed warning for the increased risk of suicidal ideation in children and adolescents. Patients taking this medication should be monitored and observed closely or clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of therapy or anytime their dose changes.