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Gabapentin controlled release - Assertio Therapeutics

Drug Profile

Gabapentin controlled release - Assertio Therapeutics

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

Latest Information Update: 20 Aug 2018

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At a glance

  • Originator Depomed; Elan Corporation
  • Developer Assertio Therapeutics
  • 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
  • New Molecular Entity No

Highest Development Phases

  • Marketed Postherpetic neuralgia
  • Discontinued Diabetic neuropathies; Hot flashes

Most Recent Events

  • 15 Aug 2018 Depomed is now called Assertio Therapeutics
  • 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
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