Navigation Links
Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
Date:2/27/2012

PARSIPPANY and LIVINGSTON, N.J., Feb. 27, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: CBRX) today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy. 

The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at </= 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial.  Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial.  In the complete response letter, FDA stated that additional clinical work would be required to support the approval.

On February 10, 2012, Columbia transferred NDA 22-139 to Watson.  Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application. 

"Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," said Paul M. Bisaro, Watson
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Watson to Present at the 2012 RBC Capital Markets Healthcare Conference
2. Watson to Present at the Citi 2012 Global Healthcare Conference
3. Watson Full Year 2011 Net Revenue Increases 29% to $4.58 Billion;
4. Watson Provides Update on Generic Lidoderm® Application
5. Watson Reaches Settlement with Mallinckrodt Over Exalgo(R)
6. Watson Confirms Court Stays Preliminary Injunction
7. Watson Announces Preliminary 2011 Non-GAAP Earnings of $4.75-$4.77
8. Watson Acquires Ascent Pharmahealth for AU$375 Million
9. Watson to Present at the 30th Annual J.P. Morgan Healthcare Conference
10. Watson to Present at Goldman Sachs Healthcare CEOs Unscripted: A View from the Top
11. Watson Launches Generic LoSEASONIQUE(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... DALLAS , Aug. 29, 2014 /PRNewswire-iReach/ -- ... Crystallography Scanner Industry, 2009-2019 is a professional and ... X-Ray Crystallography Scanner industry . The report firstly ... including its classification, application and manufacturing technology. The ... of X-Ray Crystallography Scanner listing their product specification, ...
(Date:8/29/2014)... , Aug. 29, 2014 Pomerantz LLP has ... or the "Company") (NASDAQ: EDAP ) and ... United States District Court, Southern District of ... on behalf of a class consisting of all persons ... 2013 and July 30, 2014, inclusive (the "Class Period"). This ...
(Date:8/29/2014)... , Aug. 29, 2014  BC Technical, the nation,s ... Polaris Medical Imaging, a leader in sales, service and ... acquisition allows BC Technical to continue to expand their ... MR and CT modalities. "We are ... Mark Alvarez , president and CEO of BC ...
Breaking Medicine Technology:X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 2X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 3X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 4X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 5SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3BC Technical Acquires Polaris Medical Imaging 2
(Date:8/30/2014)... 2014 The establishment and creation ... been one of the main strategies of the ... positive impact around the world. , Architecturally stellar ... trained executives and trainers deliver L. Ron Hubbard's ... Vital statistics demonstrate that significant reduction in crime, ...
(Date:8/30/2014)... 30, 2014 Hundreds of Byetta lawsuits ... to move forward in U.S. courts, Bernstein Liebhard LLP ... on July 31, 2014, Byetta and Bydureon (an extended-release ... liability claims that allege the drugs caused pancreatitis, pancreatic ... of these claims are pending in a multidistrict litigation ...
(Date:8/30/2014)... AZ (PRWEB) August 30, 2014 Hastings ... personal injury attorneys located throughout Arizona is pleased to ... This is one specific example among many cases where ... clients are able to retain a greater portion of ... after case that providing a positive solution for Arizona ...
(Date:8/30/2014)... Serving contented clients since inception, #1 ... Outsourcing is now offering discount for Labor Day ... emphasize on putting forward the best of web development ... dedicated team of professionals and web developers and designers ... even the critical issues of web development and can ...
(Date:8/30/2014)... 2014 In today’s world, a good night’s ... Snoring and sleep apnea (a medical problem where the airway ... bed partners of the rest they need to face their ... snores and 20 million people in the United States alone ... and treated; and of those treated, many cannot tolerate their ...
Breaking Medicine News(10 mins):Health News:Cradle of Aviation Museum Opens Its Doors to Long Island Scientologists 2Health News:Byetta Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Settlements in More than 80 Cases 2Health News:Byetta Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Settlements in More than 80 Cases 3Health News:Hastings and Hastings Is Pleased To Report Having Saved A Client $67,100 On A Settlement Of $610,000 2Health News:Profit By Outsourcing Offering Discount for Labor Day on all Web Development Services 2Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3
... SATURDAY, Feb. 18 (HealthDay News) -- Two factors -- a ... critical to quality of life for disabled elderly people, according ... seniors rate their quality of life as "fair to very ... seniors (white, black, Hispanic, and Chinese American) who were interviewed ...
... HealthDay Reporter , FRIDAY, Feb. 17 (HealthDay News) -- Decades-old assumptions about ... put 100 out of reach for many seniors, a new study finds. ... as you age. A team of researchers now believe that ... instead of flattening out a bit. The findings could lead to ...
... professor of international health at the Swedish medical university ... equally popular as a lecturer at international science conferences ... world. His next scheduled appearance is in a panel ... on 16-20 February. The theme of the conference is ...
... News) -- ,Eating at least three servings of fish a ... colon polyps, according to a new study. Colon polyps ... into cancer. Previous research has suggested a link between inflammation ... may reduce inflammation and help protect against the development of ...
... Association for Gerontology in Higher Education (AGHE) the ... will hold its 38th Annual Meeting and Educational Leadership ... Arlington Capital View Hotel in Arlington, VA. Media representatives ... conference provides a forum for professionals in the field ...
... Prentiss Foundation again has demonstrated its commitment to University ... Eye Institute. The gift will honor the late Benjamin ... grandfather of Prentiss Foundation trustee Elisabeth Alexander. ... and in 1893 helped found what is known today ...
Cached Medicine News:Health News: Disabled Elderly Say They Want Dignity, Control 2Health News:Living to 100 May Be Tougher Than You Think 2Health News:Professor from Karolinska Institutet now international educator 2Health News:Eating Fish May Help Ward Off Colon Polyps in Women 2Health News:Meeting to outline effective education about aging as America's senior population grows 2Health News:University Hospitals receives $5 million gift for Eye Institute 2Health News:University Hospitals receives $5 million gift for Eye Institute 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: