Topiramate extended-release - Upsher-Smith

Drug Profile

Topiramate extended-release - Upsher-Smith

Alternative Names: Qudexy XR; USL-255

Latest Information Update: 25 Jan 2017

Price : $50

At a glance

  • Originator Upsher-Smith
  • Class Antiepileptic drugs; Antimigraines; Hexoses; Ketoses; Neuroprotectants; Obesity therapies; Small molecules; Sulfonic acids
  • Mechanism of Action AMPA receptor antagonists; Carbonic anhydrase inhibitors; GABA A receptor agonists; Kainic acid receptor antagonists; Sodium channel antagonists
  • Orphan Drug Status

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

  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Lennox-Gastaut syndrome; Partial epilepsies; Tonic-clonic epilepsy
  • Preregistration Migraine

Most Recent Events

  • 13 Jan 2017 Zydus Pharmaceuticals enters into settlement agreement with Upsher Smith related to Topiramate extended release capsules
  • 09 Jun 2016 Preregistration for Migraine in USA (PO)
  • 09 Jun 2016 The US FDA tentatively approves topiramate extended release for treatment of Migraine in USA
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