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Cotempla XR-ODT FDA Approval History

FDA Approved: Yes (First approved June 19, 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 timeline for Cotempla XR-ODT

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

Further information

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