Navigation Links
Watson Files Application for Generic SEASONIQUE(R)
Date:3/4/2008

CORONA, Calif., March 4 /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 its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. Watson's levonorgestrel and ethinyl estradiol product is a generic version of Barr's SEASONIQUE(R).

On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified Barr that it had filed an ANDA with a paragraph IV certification with the FDA for a generic version of SEASONIQUE(R) asserting that the SEASONIQUE(R) patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for SEASONIQUE(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

SEASONIQUE(R) 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 difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; 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, 2007.

SEASONIQUE(R) is a registered trademark of Duramed Pharmaceuticals, Inc.

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


'/>"/>
SOURCE Watson Pharmaceuticals, Inc.
Copyright©2008 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. Watson Files FDA Application for Generic YAZ(R)
5. Watson Names Mark Durand Chief Financial Officer
6. Watson and Novartis Settle Lawsuit Over Exelon(R) Patent Litigation
7. Barr Subsidiary Sues Watson and Sandoz for SEASONALE(R) Patent Infringement
8. Watson Confirms Patent Litigation With Barr Related to Seasonale(R)
9. Watson Receives FDA Approval for Generic DuoNeb(R)
10. Watson to Distribute Alendronate Tablets
11. Medical Cost Increases to Accelerate Worldwide Over Next Five Years, Watson Wyatt Poll Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... Those ... deal with these feelings, many turn to unhealthy avenues, such as drug or alcohol ... of Marne, Michigan, has released tools for healthy coping following a traumatic event. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... HILL, N.C. , June 24, 2016 /PRNewswire/ ... healthcare decisions and regulators/payers have placed more emphasis ... new environment, patient support programs in the pharmaceutical ... for patients, medications. Consequently, pharmaceutical companies are focusing ... ensure they are providing products and services that ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
Breaking Medicine Technology: