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Mylan says FDA approvals for generic transdermal fentanyl no longer expected in 2007
By E. Janene Geiss
Philadelphia, Aug. 7 - Mylan Laboratories Inc. said Monday that it no longer anticipates additional generic transdermal fentanyl approvals during fiscal 2007, which ends March 31, 2007.
Mylan's Fentanyl Transdermal System is the only Food and Drug Administration-approved, AB-rated generic alternative to Ortho-McNeil's Duragesic patch, according to a company news release.
An FDA filing from PriCara, a unit of Ortho-McNeil, recently became available for public viewing on the FDA web site, officials said.
The filing supports Mylan's position and its request in an earlier citizen petition for the FDA to require all applicants for fentanyl transdermal systems to conduct their own individual studies to determine the effect of an overlay with their respective patches.
Based on the information in the PriCara filing, as well as the safety issues raised in the three fentanyl citizen petitions currently filed with the FDA, Mylan said it no longer anticipates that additional generic fentanyl products will be approved during its current fiscal year.
"After having reviewed this most recent filing, it is now clear that both Mylan and Ortho-McNeil agree that there are significant issues for the FDA to consider," Robert J. Coury, Mylan's vice chairman and chief executive officer, said in the release.
At this time, Mylan said it is not revising the fiscal 2007 adjusted earnings per share guidance of $1.35 to $1.55 that the company provided on July 26, as the range of guidance already allows for the potential of increased earnings based on a lack of additional generic transdermal fentanyl approvals, officials said.
Mylan is a Pittsburgh-based pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc.
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