4 Generic Versions of Intuniv ADHD Drug Launched in US

June 5, 2015
Krystle Vermes

Four separate drug manufacturers have launched generic versions of Shire's Intuniv ADHD treatment for children aged 6 to 17 years.

Four separate drug manufacturers have launched generic versions of Shire’s Intuniv ADHD treatment for children aged 6 to 17 years.

Mylan, Teva, Sandoz, and TWi Pharmaceuticals each introduced generic guanfacine hydrochloride extended-release tablets in once-daily 1-mg, 2-mg, 3-mg and 4-mg dosage strengths that can be used alone or as adjunct therapy to stimulant medications.

In a press release, Sandoz president Peter Goldschmidt noted ADHD is “one of the most common neurodevelopmental disorders of childhood.”

About 1 in 10 US children have ADHD, and half of them are diagnosed with the neurobehavioral disorder by age 6.

In light of these statistics, Brendan O’Grady, president and CEO of North America Generic Medicines for Teva, said his company “recognize(s) the need to make affordable generic treatment options available to patients with ADHD.”

The safety and efficacy of the central alpha2A-adrenergic receptor agonist has not been established in patients aged less than 6 years, and the drug is contraindicated in those with a history of a hypersensitivity reaction to Intuniv or its inactive ingredients, or other products containing guanfacine.

The drug’s labeling warns of hypotension, bradycardia, syncope sedation, somnolence, and cardiac conduction abnormalities associated with guanfacine extended-release treatment. The most common adverse reactions reported in trials include fatigue, nausea, lethargy, insomnia, and dizziness.