News Release Detail
Mylan Submits a Supplement to Its Citizens Petition Regarding Authorized Generics to the FDA
Robert J. Coury, Mylan's CEO and Vice Chairman of the Board, stated, "The damage to us through lost market opportunity, as well as to the generic industry and ultimately consumers who rely on generics to contain healthcare cost, makes this an issue that deserves to be addressed. Considerable time has passed since we filed our original petition with the FDA in February. We believe Congressional intent is clear regarding the launch of generics into the marketplace and have therefore requested that the FDA clarify its position."
Mr. Coury went on to say, "Because we anticipate that the courts will ultimately have to resolve this matter, it is imperative that the FDA responds to this important industry issue."
A copy of the original citizens petition dated February 17, 2004 and the supplement submitted to the FDA on June 28, 2004 will be filed with a Form 8-K and will be accessible to the public on the SEC's website at www.sec.gov .
In addition, Mylan's previously announced lawsuit against the FDA seeking to restore final approval for its fentanyl transdermal system will also be filed with an 8-K and be accessible to the public in an 8-k filing today.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories, Inc. and Mylan Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com .
This press release includes statements that constitute "forward-looking statements", including with regard to the resolution of the matters discussed above and the ultimate determination of those matters by the courts. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: a ruling adverse to the Company's position; other uncertainties and matters beyond management's control inherent in legal and administrative proceedings; and the other risks detailed in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
SOURCE Mylan Laboratories Inc.
06/30/2004
CONTACT:
Media, Heather Bresch
or Investors, Kris King
of Mylan
Laboratories Inc.
+1-724-514-1800
Web site: http://www.mylan.com