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Duragesic pediatric exclusivity ruling

Executive Summary

FDA decision prohibiting Mylan from launching its Duragesic generic until J&J's pediatric exclusivity expires was upheld by D.C. appeals court Nov. 30. Court says agency did not err in converting Mylan's ANDA approval from "final" to "tentative," and in treating the company's Paragraph IV certification as a Paragraph II, after a Vermont court ruled that Mylan's fentanyl patch infringed J&J's patent. Duragesic's pediatric exclusivity expires Jan. 23 (1"The Pink Sheet" Aug. 23, 2004, p. 15)...
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