Medindia
Medindia LOGIN REGISTER
Advertisement

Watson Files FDA Application for Generic YAZ(R)

Wednesday, November 7, 2007 General News
Advertisement
CORONA, Calif., Nov. 7 Watson Pharmaceuticals,Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmedthat it has filed an Abbreviated New Drug Application (ANDA) with the U.S.Food and Drug Administration (FDA) seeking approval to market a genericversion of YAZ(R) tablets prior to the expiration of patents owned by BayerSchering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (Bayer). Bayerfiled suit against Watson on November 5, 2007 in the U.S. District Court,District of Nevada, seeking to prevent Watson from commercializing its productprior to the expiration of patents numbered 6,787,531, RE 37,564 and RE37,838. Bayer's suit was filed under the provisions of the Hatch Waxman Act,resulting in a stay of FDA approval of Watson's ANDA for 30 months or untilfinal resolution of the matter before the court, whichever occurs sooner.
Advertisement

YAZ(R) (drosperinone and ethinyl estradiol tablets) is indicated for theprevention of pregnancy.

Forward-Looking Statement

Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, patents and other intellectual property rights held bycompetitors and other third parties and the uncertainty of the outcome oflitigation related to such patents and intellectual property rights; theimpact of competitive products and pricing; market acceptance of and continueddemand for Watson's products; difficulties or delays in manufacturing; andother risks and uncertainties detailed in Watson's periodic public filingswith the Securities and Exchange Commission, including but not limited toWatson's Annual Report on Form 10-K for the year ended December 31, 2006.

YAZ(R) is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)

SOURCE Watson Pharmaceuticals, Inc.
Sponsored Post and Backlink Submission


Latest Press Release on General News

This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close