Methylphenidate extended release - Neos Therapeutics

Drug Profile

Methylphenidate extended release - Neos Therapeutics

Alternative Names: Cotempla XR-ODT; Methylphenidate extended-release orally disintegrating tablet; Methylphenidate XR-ODT; NT-0102

Latest Information Update: 20 Mar 2017

Price : $50

At a glance

  • Originator Neos Therapeutics
  • Class Phenylacetates; Piperidines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Adrenergic receptor modulators; Central nervous system stimulants; Dopamine release stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Attention-deficit hyperactivity disorder

Most Recent Events

  • 20 Mar 2017 Neos Therapeutics' extended release methylphenidate is still under Preregistration trials for Attention-deficit hyperactivity disorder (In children) in USA (PO)
  • 14 Mar 2017 US FDA assigns PDUFA action date of 19/06/2017 for methylphenidate extended release for Attention-deficit hyperactivity disorder
  • 20 Dec 2016 Neos Therapeutics resubmits NDA for methylphenidate extended release to the US FDA
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