Shire Receives FDA Approval For Intuniv Extended Release Tablets

Shire has received approval from the FDA for Intuniv (guanfacine) extended release tablets for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.

Intuniv, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

Once-daily Intuniv is expected to be available in the US pharmacies in November and will come in four dosage strengths (1mg, 2mg, 3mg, and 4mg).

Mike Cola, president of Shire Specialty Pharmaceuticals, said: “Shire is proud to introduce Intuniv, providing clinicians, patients, and their families with a novel ADHD treatment option. Intuniv expands the Shire ADHD portfolio with a nonscheduled medication, allowing clinicians to optimize their overall approach toward managing ADHD and may help provide symptom control for children and teens with ADHD who often have difficulty responding appropriately to everyday situations and challenges.”