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Gablofen Approval History

  • FDA approved: Yes (First approved November 19th, 2010)
  • Brand name: Gablofen
  • Generic name: baclofen
  • Dosage form: Injection
  • Company: CNS Therapeutics
  • Treatment for: Cerebral Spasticity, Chronic Spasticity

Gablofen (baclofen) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity.

Development History and FDA Approval Process for Gablofen

Nov 23, 2010Approval FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity

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