News Release Detail
Mylan's Fentanyl ANDA's Approval Effective Upon Expiration of Alza's Patent; Mylan Maintains Fiscal 2005 Earnings Guidance of $1.30 to $1.40 Per Diluted Share
In addition, in response to Janssen Pharmaceutica Products, L.P.'s press release of March 25, 2004, Mylan has submitted correspondence to the FDA in support of the FDA's final approval of Mylan's fentanyl ANDA notwithstanding Alza's pediatric exclusivity. Mylan has filed a copy of the correspondence with a Form 8-K, which will be accessible on the SEC's website at www.sec.gov.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and 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 Company's July 2004 product launch and its projected fiscal 2005 earnings. 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: tactics by branded pharmaceutical companies and other competitors that involve seeking injunctive or other relief, or utilizing legal, regulatory or legislative strategies, in an attempt to delay or halt the Company's product introductions; the Company's ability to successfully develop, license or otherwise acquire and introduce new products on a timely basis in relation to competing product introductions; the Company's ability to obtain required FDA approvals for new products on a timely basis; uncertainties regarding continued market acceptance of and demand for the Company's products; the effects of vigorous competition on commercial acceptance of the Company's products; the high cost and uncertainty associated with compliance with extensive regulation of the pharmaceutical industry; uncertainties regarding intellectual and other proprietary property protections; possible reductions in reimbursement rates for pharmaceutical products; possible negative effects on product pricing of current or future legislative or regulatory programs; uncertainties and matters beyond the control of management, which could affect the Company's earnings guidance, as well as the subjectivity inherent in any probability weighted analysis underlying the Company's assumptions and estimates with respect to the future; 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.
CONTACT: Mylan Laboratories Inc. Heather Bresch, 724-514-1800 SOURCE: Mylan Laboratories Inc.