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FDA Approves First Generic Strattera for ADHD

FDA news release; 2017 May 30

The US Food and Drug Administration (FDA) has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.

Indications: Strattera is a selective norepinephrine reuptake inhibitor indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Dosage/administration: Dosage is as follows:

  • Children and adolescents ≤70 kg—initial daily dose, 0.5 mg/kg; target total daily dose, 1.2 mg/kg; maximum total daily dose, 1.4 mg/kg.
  • Children and adolescents >70 kg and adults—initial daily dose, 40 mg; target total daily dose, 80 mg; maximum total daily dose, 100 mg.

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine.

Adverse reactions: Most common adverse reactions (≥5% and at least twice the incidence of placebo patients):

  • Children and adolescents—Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.
  • Adults—Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation.

Citation:

US Food and Drug Administration. FDA approves first generic Strattera for the treatment of ADHD. FDA Web site. May 30, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561096.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 1, 2017.