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FDA Applies DURAGESIC(reg) Six Month Period of Pediatric Exclusivity

Janssen Pharmaceutica Products, LP, today announced that the US Food and Drug Administration (FDA) will apply the six-month period of pediatric exclusivity previously granted by the agency to DURAGESIC(reg) (fentanyl transdermal system) CII. The decision requires that the effective date of FDA approval of the application of Mylan Laboratories, Inc., for a generic fentanyl transdermal patch be changed to a date after the expiration of the DURAGESIC(reg) pediatric exclusivity period in January 2005.

The FDA action follows a recent U.S. District Court ruling by Judge William K. Sessions III in Burlington, Vermont, that the generic product from Mylan Laboratories, Inc., infringed the DURAGESIC(reg) product patent.

Janssen Pharmaceutica Products, L.P., markets DURAGESIC(reg) in the U.S. and ALZA Corporation, another Johnson & Johnson company, holds the product patent.

DURAGESIC(reg) and its active ingredient, fentanyl, are integral parts of Janssen's history. Janssen Pharmaceutica Products, L.P., researchers synthesized fentanyl in 1960, and the FDA approved DURAGESIC(reg) in 1990.

ALZA Corporation is a leading developer of drug delivery-based pharmaceutical products. More information about the company may be found at www.alza.com. Janssen Pharmaceutica Products, L.P., is based in Titusville, NJ. Its specialty areas include central nervous system disorders, pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at http://www.janssen.com.





Se aplicã DURAGESIC FDA (REG) Perioada de ºase luni de exclusivitate pediatric - FDA Applies DURAGESIC(reg) Six Month Period of Pediatric Exclusivity - articole medicale engleza - startsanatate