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Mylan believes that Matrix is the first company to file a substantiallycomplete Abbreviated New Drug Application (ANDA) containing a paragraph IVcertification for the product. Matrix filed an ANDA with the U.S. Food andDrug Administration (FDA) in early 2008.
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Daiichi Sankyo filed a lawsuit yesterday in the U.S. District Court forthe District of New Jersey alleging infringement of the sole patent relatingto Azor, which is listed in the "Orange Book" as U.S. Patent No. 5,616,599.
Mylan Inc., with a presence in more than 90 countries, ranks among theleading diversified generic and specialty pharmaceutical companies in theworld. The company maintains one of the industry's broadest - and highestquality - product portfolios, supported by a robust product pipeline; owns acontrolling interest in the world's second largest active pharmaceuticalingredient manufacturer; and operates a specialty business focused onrespiratory and allergy therapies.
This press release includes statements that constitute "forward-lookingstatements," including with regard to first to file status and pendinglitigation. These statements are made pursuant to the safe harbor provisionsof the Private Securities Litigation Reform Act of 1995. Because suchstatements inherently involve risks and uncertainties, actual future resultsmay differ materially from those expressed or implied by such forward-lookingstatements. Factors that could cause or contribute to such differencesinclude, but are not limited to: the use of legal, regulatory and legislativestrategies by competitors or other third parties to delay or prevent productintroductions; risks inherent in legal and regulatory processes; and the otherrisks detailed in the Company's filings with the Securities and ExchangeCommission. The Company undertakes no obligation to update these statementsfor revisions or changes after the date of this release.
SOURCE Mylan Inc.
