Noven Pharmaceuticals Inc’s abbreviated new drug application (ANDA) for a generic version of Duragesic (fentanyl transdermal system) has not been approved by the US FDA.

The US regulators has ceased its review of the ANDA, based on its assessment of potential safety concerns related to the higher drug content in the Noven generic product versus the Duragesic product. Its determination was made known to Noven at a meeting requested by Noven with representatives of the FDA on the afternoon of September 27, 2005.

In July 2005, the FDA issued a public advisory that it was investigating reports of death and other serious side effects from overdoses involving both the branded and generic fentanyl patches currently on the market.

Noven 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 fentanyl patch.

Noven and Endo Pharmaceuticals Inc., the US licensee of Noven's fentanyl patch, have agreed to share the cost of existing fentanyl inventories, states a company release.