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Prialt Approval History

  • FDA approved: Yes (First approved December 28th, 2004)
  • Brand name: Prialt
  • Generic name: ziconotide
  • Dosage form: Intrathecal Infusion
  • Company: Elan Corporation, plc
  • Treatment for: Pain

Prialt (ziconotide) is a non-opioid intrathecal (IT) therapy indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

Development History and FDA Approval Process for Prialt

Dec 28, 2004Approval Prialt Elan Corporation, plc - Treatment for Severe Chronic Pain
Jun 28, 2004Elan Files Amendment to New Drug Application for Prialt for Severe Chronic Pain Based on Additional Efficacy and Safety Data

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