Cotempla XR-ODT Approval History

• FDA approved: Yes (First approved June 19th, 2017)
• Brand name: Cotempla XR-ODT
• Generic name: methylphenidate
• Dosage form: Extended-Release Orally Disintegrating Tablets
• Company: Neos Therapeutics, Inc.
• Treatment for: ADHD

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Development History and FDA Approval Process for Cotempla XR-ODT

Date	Article
Jun 19, 2017	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
Dec 20, 2016	Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD
Nov 10, 2015	Neos Therapeutics Receives Complete Response Letter From the FDA for Cotempla XR-ODT
Jan 12, 2015	Neos Therapeutics Announces Submission of NDA for its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) for the Treatment of ADHD

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