Navigation Links
Watson Files FDA Application for Generic YAZ(R)
Date:11/7/2007

- Paragraph IV Patent Challenge Underway -

CORONA, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of YAZ(R) tablets prior to the expiration of patents owned by Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (Bayer). Bayer filed suit against Watson on November 5, 2007 in the U.S. District Court, District of Nevada, seeking to prevent Watson from commercializing its product prior to the expiration of patents numbered 6,787,531, RE 37,564 and RE 37,838. 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 until final resolution of the matter before the court, whichever occurs sooner.

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

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson'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.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
2. Watson Wyatt Identifies Major Benefit Trends During Open Enrollment Season
3. Texas Affiliates of Susan G. Komen for the Cure, Sen. Kirk Watson, Rep. Patrick Rose, Singer Kelly Willis, Breast Cancer Survivors and Activists Rally for Passage of Proposition 15
4. Alvarado Hospital Files Countersuit Against Blue Shield
5. Par Pharmaceutical Files Form 10-K for 2006 -- Company to Hold First Analysts Meeting September 28, 2007
6. Pharsight Files Application for Nasdaq Capital Market Listing
7. Gentiva(R) Health Services Files Universal Shelf Registration Statement
8. Paramount Acquisition Corp. Files Amendment to Preliminary Proxy Statement for Proposed Acquisition of Chem Rx
9. CIGNA Behavioral Health Offers Members Online Provider Profiles
10. American Media Operations, Inc. Files Form 10-Q For First Quarter 2007
11. RxElite Files Registration Statement with Securities and Exchange Commission
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/30/2016)... ... 30, 2016 , ... “Aging well is a challenge for all of us, but there are things we can ... Kohli . “Research is showing more and more that there are simple, yet important steps ... as we age.” Top priorities Dr. Kohli’s recommends for her patients include;, , ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... ... Two Ten Footwear Foundation, the national charitable foundation serving the footwear industry, has ... 8,000 volunteers representing more than 130 companies across 23 states during the months ...
(Date:4/29/2016)... ... April 29, 2016 , ... The ... nation’s productivity, stability, even security. Most importantly, employees are the single most important ... are American workers so unhappy? , Just under half of American workers are ...
(Date:4/29/2016)... Petersburg, Fla. (PRWEB) , ... April 29, 2016 ... ... Children’s Hospital surgeon reveals that infants born with severe congenital diaphragmatic hernia have ... babies is born with congenital diaphragmatic hernia (CDH)—a condition where the diaphragm fails ...
(Date:4/29/2016)... ... 2016 , ... The Gluten-Free Certification Program (GFCP), in partnership ... launch of the GFCP Scoop in response to consumer demand for ... GFCP Scoop site is to keep the gluten-free community updated about ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... , April 28, 2016 ... development of innovative peptide and gene-based immunotherapeutics and vaccines for ... will be presenting at the 3rd Annual Growth Capital ... 5 th , 2016 at Caesars Palace in Las Vegas, Nevada.  ... am on Wednesday, May 4 th by Dr. ...
(Date:4/27/2016)... --   , Total Sales ... Sales  Clinical sales grow 16% year-over-year  , ... OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser ... quarter ended March 31, 2016 and provided an update ... strategy. First Quarter 2016 Revenue Results by ...
(Date:4/27/2016)... 2016  Bayer Animal Health today announced that ... University of Florida College of Veterinary Medicine, is ... Communication Award (BECA). Brittany was selected from entries ... total of $70,000 in scholarship funds through the ... has provided a total of $232,500 in scholarship ...
Breaking Medicine Technology: