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FDA Approves QuilliChew ER

Indicated for treatment of ADHD

The FDA has approved QuilliChew ER chewable tablets for the treatment of attention deficit hyperactivity disorder (ADHD).

Indications: QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of ADHD.

Dosage and administration: For patients 6 years and above, the recommended starting dose is 20 mg given orally once daily in the morning. Dosage may be titrated weekly in increments of 10 mg, 15 mg or 20 mg per day. Daily dosage above 60 mg is not recommended.

Efficacy and safety: The efficacy of QuilliChew ER was evaluated in a double blind, randomized, placebo-controlled, parallel group laboratory classroom study in 90 children ages 6 to 12 years old with a diagnosis of ADHD. The average of treatment effects across all time points was statistically significantly superior to placebo.

Side effects/risks: The most common adverse reactions are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.

Citation:

Pfizer receives U.S. FDA approval of new QuilliChew ER™ (methylphenidate hydrochloride) extended-release chewable tablets CII [news release]. New York, NY: Alexion; December 7, 2015. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_rec....

Accessed December 22, 2015.

Quillichew ER [package insert]. New York, NY: Pfizer, Inc; 2015. http://labeling.pfizer.com/ShowLabeling.aspx?id=2577. Accessed December 22, 2015.