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: 23 Dec 2016

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Attention-deficit hyperactivity disorder

Most Recent Events

  • 20 Dec 2016 Neos Therapeutics resubmits NDA for methylphenidate extended release to the US FDA
  • 20 Dec 2016 The US FDA sets a six-month PDUFA date for NDA review for Attention-deficit hyperactivity disorder
  • 28 Jul 2016 Neos Therapeutics completes a phase I bioequivalence trial
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