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Watson Seeks FDA Approval For Generic Version Of Beyaz

DOW JONES NEWSWIRES Watson Pharmaceuticals Inc. (WPI) has filed an abbreviated new-drug application with the U.S. Food and Drug Administration for its generic version of Bayer HealthCare Pharmaceuticals Inc.'s Beyaz oral contraceptive. Bayer HealthCare, along with parent Bayer Pharma AG (BAYRY, BAYN.XE), and Merck KGaA (MKGAY, MRK.XE) subsidiary Merck & Cie filed a lawsuit against Watson in a Delaware district court Friday to prevent Watson from launching a generic version of Beyaz prior to the expiration of its patent. Watson said it believes it may be a "first applicant" to file an abbreviated new-drug application for a generic version of Beyaz and may be entitled to 180 days of market exclusivity, if the application is approved. Watson has seen strong sales of its generics as health-care companies and consumers reduce spending on health-related products and services. Watson also has a stable of branded drugs focused on urology and women's health. Last month, the company said its results for 2011 were stronger than expected as it saw strong growth of its generics business, especially from new generic Lipitor sales. Watson shares rose 15 cents to $58.14 in after-hours trading. The stock is down 11% in the past three months. -By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com

Stock News for Watson (WPI)
DateTimeHeadline
11/09/201215:37:51FDA Panel Splits on Merck Plan to Sell Bladder Drug Over-The-Counter
10/25/201214:46:46Mylan CEO Eyes Acquisitions Valued at More than $4 Billion
10/23/201209:01:03U.S. HOT STOCK FUTURES: HOT STOCKS TO WATCH
10/15/201218:00:11FTC Clears Watson-Actavis Deal, With Conditions
10/12/201217:05:43Watson Pharmaceuticals Gains FDA Approval for Two Generics
09/27/201216:18:30Jumbo Deals Push Monthly Corporate Bond Volume to $115 Billion
08/15/201211:00:29Watson Pharma Sues FDA
07/13/201209:21:00Watson Pharmaceuticals: FDA Approves Generic of Teva's Plan B...
07/10/201204:08:08Correction to Shire's Generic Adderall XR Approval Story On June...
06/27/201210:28:00West Virginia Attorney General Sues Drug Distributors in Pill...
06/25/201217:49:29Watson Seeks FDA Approval Of Generic Pristiq
06/25/201209:21:18Shire Sinks On Generic Adderall XR Approval But Rebound Seen
05/29/201214:13:08Mylan Launches Generic Version of Blockbuster Lipitor
05/29/201209:15:58US HOT STOCK FUTURES: HOT STOCKS TO WATCH
04/30/201209:19:40US STOCK FUTURES: HOT STOCKS TO WATCH
04/27/201210:54:37Pharma M&A Surge Spurred By Necessity And Opportunity
04/26/201216:10:34US Stocks Climb As Housing Data Outweighs Weak Labor, Europe...
04/26/201211:27:59INTERVIEW: Actavis CEO To Leave Company After Watson Integration
04/25/201217:25:51Deutsche Bank Takes EUR257 Million Hit On Actavis-Watson Deal
04/24/201208:26:02Watson, Actavis To Unveil EUR4.5 Billion Merger Deal Wednesday

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