Mylan Laboratories To Refile Hatch-Waxman Suit Vs. FDA

Law360, New York (September 1, 2004, 12:00 AM EDT) -- Mylan Pharmaceuticals is preparing a new lawsuit against the U.S. Food and Drug Administration over the legality of so-called “authorized generics” after surprisingly withdrawing its original complaint earlier this week.

Mylan sought dismissal of its first complaint without prejudice Monday after oral arguments in court last week revealed grounds for a broader case that will likely raise antitrust issues, the company said.

U.S. District Judge Irene Keeley had been expected to rule Monday on Mylan's original complaint. At a hearing last week, she called Mylan's case...
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