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FDA Decision On Mylan Duragesic ANDA Upheld By D.C. Court

Executive Summary

FDA did not err in barring Mylan's transdermal fentanyl patch from coming to market until after Johnson & Johnson/Alza's pediatric exclusivity for Duragesic expires Jan. 23, a D.C. federal court said

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Duragesic pediatric exclusivity ruling

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)...

Duragesic pediatric exclusivity ruling

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)...

Mylan Takes “Authorized” Generics Fight To Congress, FTC, Courts

Mylan is taking its fight against "authorized" generics beyond FDA to Capitol Hill, the Federal Trade Commission and the federal courts

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