Navigation Links
Watson Pharmaceuticals Announces FDA Inspection of Florida Facilities
Date:2/13/2008

CORONA, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has initiated an inspection of the company's Florida facilities. No information regarding the duration or outcome of the inspection is known.

Since September 2005, the Davie, Florida manufacturing facility has been under Official Action Indicated ("OAI"). During that time, Watson has continued to file Abbreviated New Drug Applications ("ANDAs") for product candidates to be manufactured at this site. However, FDA approval of pending ANDAs has been withheld pending positive resolution of the OAI status. While a resolution to the OAI status may enable product candidates to be approved, it does not ensure that any such ANDAs will be approved or, if approved, will be launched. The OAI status does not affect manufacture of products at the Davie, Florida facility that have already been approved for manufacture at that facility, nor does it affect Watson's other locations.

Watson's Davie, Florida facility was acquired in November 2006 as part of Watson's acquisition of Andrx Corporation.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses. For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

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, the ability to timely resolve with the FDA the pending Official Action Indicated status of the Davie, Florida manufacturing facility; 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, 2006.

(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:10/13/2017)... ... , ... As health professionals work to improve their approach to healthcare, there ... more than filling out a survey; in many cases health professionals and patients are ... care and research on the importance of active engagement with patients and members of ...
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family Medicine's (ABFM) ... and Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. Newton ... until Dr. Puffer’s retirement at the end of 2018. Upon assuming the role of ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... ... 13, 2017 , ... Lori R. Somekh, founder of the Law Office ... of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office ... forum to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
Breaking Medicine News(10 mins):
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., ... analytics, today announced that it has been ranked #1 by ... Black Book™ Rankings 2017 User Survey. ZirMed was recognized ... for large hospitals and medical centers over 200 beds and ... Book,s healthcare technology user survey history. ...
(Date:9/18/2017)... 2017 EpiVax, Inc. ("EpiVax") a ... immune engineering, today announced a new NIH-funded ... ... and presents a challenge for traditional flu ... be effective. Using state-of-the-art bioinformatics and molecular modeling methods, ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , ... supply chains, has published the first annual edition of its Global CSR ... than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed ... ... & Performance Index ...
Breaking Medicine Technology: