The FDA has ceased its review of the application, based on its concerns related to the higher drug content in the Noven generic product versus the branded Duragesic product.
The announcement also comes as a blow to Endo Pharmaceuticals which has acquired US rights to Noven’s fentanyl patch.
In July 2005, the FDA announced that it was investigating reports of death and other serious side effects from overdoses involving both the branded and generic pain patches already on the market that contain the active ingredient fentanyl.
In a statement, Noven said that it strongly disagrees with the FDA’s conclusions regarding its pending ANDA, and will be evaluating available avenues by which it may continue to pursue approval of the generic patch.