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Ionsys FDA Approval History

FDA Approved: Yes (Discontinued) (First approved May 22, 2006)
Brand name: Ionsys
Generic name: fentanyl
Dosage form: Iontophoretic Transdermal System
Company: The Medicines Company
Treatment for: Pain

Marketing Status: Discontinued

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 timeline 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

Further information

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