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