PITTSBURGH, PA (Aug. 31 2004) — Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has filed a notice of voluntary dismissal without prejudice in the United States District Court for the Northern District of West Virginia in its lawsuit against the Food and Drug Administration (“FDA”) on the issue of authorized generics. In a letter to the court submitted along with the dismissal notice, counsel for Mylan noted that counsel for both FDA and Procter & Gamble disclosed facts and positions that have a significant bearing on the “authorized generic” question and the considerable anticompetitive effects of authorized generics on the pharmaceutical industry. Mylan now believes that additional potential claims may be available to the industry.
Mylan Vice Chairman and CEO, Robert J. Coury, stated “Mylan dismissed this lawsuit without prejudice in order to have the ability to refile the lawsuit taking into consideration the additional facts presented during oral argument.
“We have every intention of taking all necessary steps to end this practice.” Mr. Coury added, “The FDA by its actions has eliminated the 180-day exclusivity reward specifically provided to generic companies in the Hatch Waxman Amendments. Congress could not have intended such a result.”
A copy of Mylan’s August 30th letter to the Court will be filed with the SEC with a Current Report on Form 8-K.