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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.


US Food and Drug Administration. FDA approves first generic Strattera for the treatment of ADHD. FDA Web site. May 30, 2017. Accessed June 1, 2017.