PITTSBURGH, Nov. 4 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma’s Keppra(R).
Robert J. Coury, Mylan’s Vice Chairman and CEO, commented: “We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond.”
Mylan and UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan’s ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the ‘639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.
Levetiracetam Tablets had U.S. sales of approximately $1 billion for the 12 months ending Sept. 30, 2008, for these three strengths.
This press release includes statements that constitute “forward-looking statements,” including with regard to the launch of Levetiracetam, the litigation settlement and expectations for future goals. 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: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; uncertainties regarding market acceptance and demand for the product; risks inherent in contracts, including the breach or unenforceability of any key provision; changes in economic and financial conditions affecting the company’s business; uncertainties and matters beyond the control of management; and the other risks detailed in the company’s 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.
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
CONTACT: Media, Michael Laffin, +1-724-514-1968, or Investors, Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
Web site: http://www.mylan.com/
