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Mylan Pharmaceuticals, Inc. (MYL) Receives Final FDA Approval For Oxybutynin Chloride Extended-release Tablets |
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11 Nov 2006 |
Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Applications (ANDAs) for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg, and Mylan has launched these products immediately.
PITTSBURGH, PA, USA | Nov 10, 2006 | Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Applications (ANDAs) for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg, and Mylan has launched these products immediately. Oxybutynin Chloride ER Tablets are the generic version of Alza Corporation's Ditropan XL(R) Extended-release Tablets. Ditropan XL(R) had U.S. sales of approximately $380 million during the 12-month period ended June 30, 2006, with more than 82% of the volume in the 5 mg and 10 mg strengths, according to IMS.
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented: "This is the latest milestone achievement in Mylan's long history of successfully developing difficult to formulate and difficult to manufacture generic products. Mylan has once again differentiated itself in the industry through the successful development of this product, and based on the limited number of competitors that have filed oxybutynin applications, we expect that it will be a valuable component of our product portfolio for the 180 days of market exclusivity and beyond."
Mylan is the first generic drug company to file ANDAs with the FDA for 5 mg and 10 mg Ditropan XL(R), and as such, the company has 180 days of market exclusivity for those strengths. Mylan has entered into two agreements with Ortho-McNeil Pharmaceuticals and Alza that ensures Mylan's ability to launch the 15 mg strength at market formation.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, please visit http://www.mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to the product's expected role in the Company's portfolio and anticipated market exclusivity. 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 possible negative effects of any interruption of manufacture of the products; uncertainties regarding market acceptance and demand for the products; dependence on third-party suppliers and distributors for raw materials; risks inherent in contracts, including the breach or unenforceability of any key provision; 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. |
