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FDA Approves Pfizer's QuilliChew ER™ Chewable Tablets for ADHD

December 7, 2015

The US Food and Drug Administration (FDA) has approved Pfizer's QuilliChew ER chewable tablets to treat attention deficit hyperactivity disorder in patients age 6 and older. The tablets are expected to be available in pharmacies in the first quarter of 2016.

QuilliChew ER is available in multiple dosage strengths with scored tablet options--20 mg scored, 30 mg scored, and 40 mg unscored--that are chewable and can be taken with or without food.

QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate or other components of QuilliChew ER and hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported. QuilliChew ER is also contraindicated during treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.

Pfizer also offers liquid Quillivant XR® (methylphenidate HCl) CII for the treatment of ADHD in patients older than 6 years.

Central nervous system stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

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