ALZA resubmits New Drug Application for Ionsys

New York, Nov. 28 - ALZA Corp. said it has resubmitted its New Drug Application for Ionsys (fentanyl hydrochloride Patient-Activated Transdermal System (PATS) 40 mcg/dose) to the Food and Drug Administration.

The resubmission is in response to the approvable letter received in mid-2004.

Ionsys is the first product in development to incorporate ALZA's proprietary E-Trans iontophoretic transdermal drug delivery system. The system delivers drug systemically by using low-level electrical energy to actively transport drugs through intact skin.

The active ingredient of Ionsys is an opioid analgesic, fentanyl hydrochloride.

ALZA originally submitted its Ionsys application in September 2003. If the resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months, under the Prescription Drug User Fee Act.

Ionsys is also awaiting approval in the European Union.

ALZA is a subsidiary of New Brunswick, N.J., health care products company Johnson & Johnson.

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