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FDA Approves Cotempla XR-ODT for ADHD Patients 6-17

Neos Therapeutics, Inc. news release; 2017 Jun 19

Neos Therapeutics, Inc., has announced that the US Food and Drug Administration (FDA) approved Cotempla XR-ODT, the first and only methylphenidate extended-release orally disintegrating tablet, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 to 17 years. Neos Therapeutics is headquartered in Grand Prairie, TX.

Indications: Cotempla XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of ADHD in pediatric patients aged 6 to 17 years.

Dosage/administration: Recommended starting dose for pediatric patients aged 6 to 17 years is 17.3 mg given orally once daily in the morning. Dosage may be increased weekly in increments of 8.6 mg to 17.3 mg per day. Daily dosage above 51.8 mg is not recommended. Patients are advised to take Cotempla XR-ODT consistently either with food or without food.

Adverse reactions: Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decrease, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.


Neos Therapeutics announces FDA approval of Cotempla XR-ODT™ (methylphenidate) extended-release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old. [news release]. Dallas and Fort Worth, Texas: Neos Therapeutics, Inc. June 19, 2017. Accessed June 21, 2017.