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Ionsys Approval History

  • FDA approved: Yes (First approved May 22nd, 2006)
  • Brand name: Ionsys
  • Generic name: fentanyl
  • Dosage form: Iontophoretic Transdermal System
  • Company: ALZA Corporation
  • Treatment for: Pain

Ionsys is a needle-free, patient-activated iontophoretic transdermal analgesic system which uses a weak electric current to rapidly deliver fentanyl across the skin and into the bloodstream. Ionsys is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization.

Development History and FDA Approval Process for Ionsys

Nov 28, 2005ALZA Corporation Resubmits U.S. New Drug Application for IONSYS (Fentanyl HCl Patient-Activated Transdermal System)
Jul 27, 2004ALZA Corporation Receives Approvable Letter Regarding IONSYS, an Iontophoretic, Fentanyl-containing, Transdermal Analgesic

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