PITTSBURGH, Feb. 14 /PRNewswire-FirstCall/ -- In response to several inquiries, Mylan Inc. confirmed today that its matrix design Fentanyl Transdermal System (FTS) is not part of the widespread recall being conducted by Ortho-McNeil-Janssen Pharmaceuticals, Inc. Ortho-McNeil reported that all lots of 25 mcg/hr Duragesic(R) CII patches sold by PriCara in the United States and all 25 mcg/hr Fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies because they may have a cut along one side of the drug reservoir within the patch. The result is possible release of Fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to Fentanyl gel.
Unlike all other U.S. marketed Fentanyl patches, Mylan’s FTS is a matrix patch, not a reservoir patch, and therefore does not leak.
Mylan Vice Chairman and CEO Robert J. Coury commented: “We have always believed that our Fentanyl Transdermal System is differentiated from all other Fentanyl patches in the U.S. market because of its unique matrix design. This is an important product characteristic that should be recognized and understood when choosing a Fentanyl Transdermal System.”
Mylan’s FTS was the first generic Class II narcotic transdermal product approved by the U.S. Food and Drug Administration.
Mylan Inc. is one of the world’s leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry’s broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan’s fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas. For more information about Mylan, please visit www.mylan.com.
CONTACT: Media, Mike Laffin or Investors, Kris King, both of Mylan Inc.,
+1-724-514-1800
Web site: http://www.mylan.com/
