Navigation Links
Watson Files FDA Application for Generic LYBREL(R)
Date:3/13/2008

- Paragraph IV Patent Challenge Underway -

CORONA, Calif., March 13 /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 tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets which is indicated for the prevention of pregnancy.

Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

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 st
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Barr Subsidiary Sues Watson for SEASONIQUE(R) Patent Infringement
2. Watson Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Results; Provides 2008 Outlook
3. Watson to Present at the 2008 Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
4. Warner Chilcott and Watson Pharmaceuticals Announce Launch of Tilia(TM) Fe
5. Watson Receives FDA Approval for Generic Accuneb(R)
6. Watson to Present at the Bear Stearns 20th Annual Healthcare Conference
7. CryoCor Files Patent Infringement Lawsuits Against CryoCath
8. Omeros Corporation Files Registration Statement for Proposed Initial Public Offering
9. TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders
10. Lexicon Files Investigational New Drug Application for LX1032 as a Potential Treatment for Carcinoid Syndrome
11. Roche Files IND for Second Genmab Antibody
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... The report “Pharmacy Automation Systems ... and Labeling Systems, Table-top Counters) by End-user (Inpatient ... & Trends to 2019” analyzes and studies the ... America, Europe, Asia-Pacific, and the Rest of the ... 30 figures spread through 300 pages and in-depth ...
(Date:10/20/2014)... PARK, Calif. , Oct. 20, 2014 /PRNewswire/ ... today that the Company has signed a Notice ... of Regenerative Medicine (CIRM), effective October 1, 2014.  ... Clinical Development payments and the release of additional ... million CIRM grant award for clinical development of ...
(Date:10/20/2014)... 20, 2014  GenVec, Inc. (NASDAQ: GNVC ) ... Ph.D., from its board of directors effective on October 24, ... and served as its chairman from June 2006 to November ... and Corporate Governance and Audit Committees of the board.  ... decade of dedicated service to GenVec, and its stockholders," said ...
(Date:10/20/2014)... Earle Martin , Chief Executive ... Ellen Teplitzky, an experienced attorney specializing in business ... has joined the firm as Director of Legal ... NDA Partners provides legal services, including research, ... top law firms and their clients in cases ...
Breaking Biology Technology:Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 2Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 3Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 4Zola P. Horovitz To Retire From GenVec Board 2NDA Partners Appoints Ellen Teplitzky, JD as Director of its Legal Services Practice 2
... Syngenta today announced that it has acquired Georgia-based ... protection technology to the company,s portfolio. Circle One Global ... a toxin that can develop in crops such as corn ... , "The acquisition of this technology adds an important ...
... ... Biotechnology Laboratory, and support US and European power supplies. , ... Williamstown, NJ (PRWEB) June 11, 2009 -- ... box. The CS230000 and CS230001 both are new Biotechnology kits from A-WIT Technologies. Choose ...
... ... financial services offerings to further meet the needs of emerging businesses. ... on Demand - NSS partners with their clients acting as an outsourced ... Solutions team equips its clients with multiple game plans; a blue print ...
Cached Biology Technology:Syngenta Acquires Innovative Bio-Control Technology to Improve Usable Crop Yields 2Syngenta Acquires Innovative Bio-Control Technology to Improve Usable Crop Yields 3A-WIT Technologies Releases World's First Low Cost C Stamp(TM) Based Biotechnology Laboratory in a Box 2Next Stage Solutions Announces Three New Financial Services For Emerging Business 2Next Stage Solutions Announces Three New Financial Services For Emerging Business 3
(Date:10/15/2014)... 44th Rosenstiel Award for Distinguished Work in Biomedical Science ... mechanisms of genomic instability and its implications for the ... alumnus to win the Rosenstiel Award; the first, Rod ... is the Charles A. Janeway Professor of Pediatrics and ... investigator at the Howard Hughes Medical Institute at Boston ...
(Date:10/14/2014)... new study published in Cancer Research shows ... and colon cancers—can promote the development of skin cancers ... and survival of sun-damaged skin cells. , Previously considered ... proteins called sirtuins that help regulate genomic stability and ... SIRT6 helps repair DNA damage, which can lead to ...
(Date:10/14/2014)... questions is how to produce enough food to feed ... and Agriculture Organization of the United Nations predicts that ... years to feed a growing global population, and plants ... food production. Plants—grains, cereals, fruits, vegetables, and more—feed ... research must tap into our knowledge of how plants ...
Breaking Biology News(10 mins):Brandeis awards 44th Rosenstiel Award to pioneering geneticist Fred Alt 2Two-faced gene: SIRT6 prevents some cancers but promotes sun-induced skin cancer 2Building a bridge from basic botany to applied agriculture 2Building a bridge from basic botany to applied agriculture 3
... Northern Arizona University and the National Center for Ecological ... circuit theory to predict gene flow across landscapes. Their ... the best spots for wildlife corridors, which are crucial ... similarities between circuit theory and ecological connectivity, said Brad ...
... and Post-It Notes Three things that started out as obscure ... will the next idea to stick with modern society look ... a humble lizard, according to a University of Calgary biologist ... to virtually any surface, including glass., Unlike most creatures, geckos ...
... University of the Basque Country (UPV/EHU), an in vitro culture ... reproduce the gene regulation that is expressed in these cancer ... patients. This in vitro culture model provides a simple tool ... factors regulating this expression, as well as a simple form ...
Cached Biology News:Model connects circuit theory to wildlife corridors 2Sticky questions tackled in gecko research 2It is important to demonstrate the influence of the microenvironment in the process of metastasis 2It is important to demonstrate the influence of the microenvironment in the process of metastasis 3
Sheep polyclonal to Quinolone ( Abpromise for all tested applications). Antigen: Norfloxacin(N)conjugated to BSA...
...
...
... the 9, 10, 12, and 13 positions. It ... for the quantification of 9(S)-HODE by GC- or ... of linoleic acid in both plants and animals. ... an esterified component of membrane phospholipids and in ...
Biology Products: