Gabapentin controlled release - Depomed

Drug Profile

Gabapentin controlled release - Depomed

Alternative Names: DM-1796; DM-5689; Gabapentin ER; Gabapentin extended release; Gabapentin Gastric Retention; Gabapentin GR; Gralise; Serada

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Depomed; Elan Corporation
  • Developer Depomed
  • Class Amines; Aminobutyric acids; Analgesics; Antiepileptic drugs; Antimanics; Antiparkinsonians; Anxiolytics; Cyclohexanecarboxylic acids; Small molecules
  • Mechanism of Action CACNA2D1 protein modulators; GABA receptor agonists
  • Orphan Drug Status

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

    Yes - Postherpetic neuralgia
  • 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

  • Marketed Postherpetic neuralgia
  • Discontinued Diabetic neuropathies; Hot flashes

Most Recent Events

  • 29 Apr 2016 Biomarkers information updated
  • 04 Mar 2013 Advisory Committee for Reproductive Health Drugs votes against the approval of gabapentin controlled release for Hot flashes in USA
  • 15 Oct 2012 The US FDA sets PDUFA date in May 2013 for NDA review for Hot flashes
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