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European Commission approves ALZA's Ionsys
Mountain View | Wednesday, February 1, 2006, 08:00 Hrs  [IST]

The European Commission has granted marketing authorisation in the 25 member states of the European Union for the use of ALZA Corporation's Ionsys (fentanyl hydrochloride iontophoretic transdermal system).

According to a Johnson & Johnson release, Ionsys is the first needle-free, iontophoretic, patient-controlled transdermal system to receive marketing authorisation, and is indicated for the management of acute moderate to severe post-operative pain, for use by adults, in a hospital setting only.

Ionsys is a compact, non-invasive, self-contained and pre-programmed analgesic system. Designed to adhere to a patient's upper arm or chest, the system uses a low level electrical current to deliver the medication directly through the skin and into the bloodstream with the push of a button.

Ionsys will be marketed in the European Union by Janssen-Cilag companies, which are affiliates of Johnson & Johnson. ALZA Corporation, the Johnson & Johnson affiliate that developed Ionsys, is working on the manufacturing processes and scale up, and launch is expected in 2007.

Ionsys is currently under review by the US Food and Drug Administration, and upon approval, Ortho-McNeil Inc., will market the product in the US.

ALZA Corporation is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable and liposomal technologies.

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