Navigation Links
FDA Issues Complete Response Letter for Low Dose Oral Contraceptive
Date:1/27/2010

ARDEE, Ireland, Jan. 27 /PRNewswire-FirstCall/ -- Warner Chilcott plc (Nasdaq: WCRX) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).  

The letter states that during FDA inspections of the third-party drug substance manufacturing facility and control testing laboratory used to support the application deficiencies were noted that remain unresolved.  Satisfactory resolution of these deficiencies is required before the application can be approved.  No efficacy or safety issues were raised by the FDA in the letter.

Warner Chilcott intends to work closely with the FDA and its third-party partners whose facilities were cited in the complete response letter to resolve these issues as rapidly as possible. Until that time, the Company's primary promotional focus within the U.S. hormonal contraceptive market continues to be LOESTRIN 24 Fe.

The Company

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the U.S. and Western European pharmaceuticals markets. Warner Chilcott is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G.

Warner Chilcott's Forward Looking Statements:

This press release contains forward-looking statements, inc
'/>"/>

SOURCE Warner Chilcott plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... than a third of reproductive-aged women enrolled in Medicaid, and ... a prescription for an opioid pain medication each year during ... Mortality Weekly Report (MMWR). Opioids are typically ... pain.  They are also found in some prescription cough medications. ...
(Date:1/23/2015)... 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating ... Inc. ("Advaxis" or the "Company") (NASDAQ: ADXS ... duties to shareholders. On January 21, 2015, ... that Advaxis had misrepresented the clinical data for its ...
(Date:1/23/2015)... Fla. , Jan. 23, 2015  HyGreen, Inc., a ... agreement and partnership with RCA Medical, a subsidiary of ... . Each year, hundreds of millions ... care-associated infections as organisms are transmitted from patient to ...
Breaking Medicine Technology:Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
... even minor orthopaedic trauma can lead to medical problems ... Feb. 25 Pregnant women who experience orthopaedic trauma ... prenatal complications if they receive care at a medical ... injuries, according to a study presented today at the ...
... New research offers hope, propels treatment for common orthopaedic ... and the Orthopaedic Research and Education Foundation (OREF) presented ... gap between basic research and clinical medicine, at the ... Orthopaedic Surgeons (AAOS) ( http://www.aaos.org/ ) . ...
Cached Medicine Technology:Orthopaedic Injury: High Risk to Pregnant Women 2Orthopaedic Injury: High Risk to Pregnant Women 3Applying Clinical Findings to the Practice of Medicine 2Applying Clinical Findings to the Practice of Medicine 3Applying Clinical Findings to the Practice of Medicine 4Applying Clinical Findings to the Practice of Medicine 5
(Date:1/23/2015)... 23, 2015 Hastings and Hastings, a law ... a record number of legal representation client review requests for ... been a steady rise in the number of slip and ... home throughout the Valley. With that said, a large number ... by an experienced law firm. Hastings and Hastings is a ...
(Date:1/22/2015)... 22, 2015 Liberty University has received accreditation ... program from the Council for Accreditation of Counseling & ... Liberty’s Center for Counseling & Family Studies , is ... the university’s new School of Behavioral Sciences. Prior to the ...
(Date:1/22/2015)... January 22, 2015 Woodloch Pines, an ... been selected by TripAdvisor as the number one best large ... best in the world for their annual Travelers’ Choice Awards. ... community . The website is home to millions of unbiased ...
(Date:1/22/2015)... VogueQueen is a seasoned and trusted leader ... designers are thrilled to have it lead the wedding dress ... collection of prom dresses for the global market. , “The ... vision and he focuses on continuing the goal of operational ...
(Date:1/22/2015)... 22, 2015 Blue Cross and Blue Shield ... exemplify what it means to “Live Fearless.” , ... to share their stories about how they or someone they ... others by living in the moment. By telling these types ...
Breaking Medicine News(10 mins):Health News:Hastings and Hastings Reports a Record Number of Client Review Requests for Slip and Fall Accidents in 2014 2Health News:Liberty University's Resident Master’s Counseling Program Receives CACREP Accreditation 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2
... a correlation between an extreme form of sleep disorder, REM ... parkinsonism. ,Patients with RBD have a high probability ... system atrophy, because all of these conditions appear to stem ... conducted by a team of researchers led by Bradley Boeve ...
... concern over rising complaints that doctors are prescribing unnecessary ... a close watch on the doctors. ,The ... doctors to prescribe only generic medicines and monitor the ... ,There have been instances wherein doctors have insisted ...
... Board of Regents today approved a proposed campaign to ... the first phase of UCSF Medical Center at ... a 289-bed, integrated medical center to serve children, women ... south of UCSFs existing 43-acre life sciences campus at ...
... insurance coverage for mental illness does not increase usage ... children with mental illness, a Yale School of Medicine ... ,Prior research has left policymakers with the impression ... nor confer much benefit, said Colleen Barry, assistant professor ...
... people may die needlessly each year due to the failure ... UK hospitals , say experts in this weeks BMJ. ... the issue last month by the National Institute for Health ... weeks journal. ,It is estimated that VTE kills ...
... the Hindustan Lever Limited (HLL) in Kodaikanal, a popular hill ... traveled all the way to Bombay in western India and ... to raise to raise the issues of mercury contamination and ... Annual General Meeting (AGM). ,The HLL had closed ...
Cached Medicine News:Health News:Researchers Find Link Between Sleep Disorder and Dementia 2Health News:Rajasthan Government Urged to Keep a Close Watch on Doctors 2Health News:UC Regents Approve Fundraised Campaign for UCSF Medical Center at Mission Bay 2Health News:Coverage for Childrens Mental Illness Reduces Out-of-Pocket Spending 2Health News:25,000 Needless Deaths Each Year Due to Failure to Tackle Blood Clots in Hospital 2Health News:Poisoned Workers of Hindustan Lever Demand Treatment 2Health News:Poisoned Workers of Hindustan Lever Demand Treatment 3Health News:Poisoned Workers of Hindustan Lever Demand Treatment 4
Provides the security of suture and ease of automated knot tying for vascular closure of 5-8F....
... cardiac surgery patients require progressive solutions that ... return to everyday life. Since the ... have been able to provide nearly 400,000 ... care:, Faster ambulation , Shorter hospital ...
... CF-60DSi is an all-digital Fundus camera system that ... efficient workflow. The Canon CF-60DSi ... EOS-1Ds series SLR digital camera features a "full ... resolution and the new ICG unit, which features ...
... Intacs prescription inserts are an ophthalmologic medical ... of myopia from -1.00 to -3.00 diopters.* ... of the patient's central optical zone, the ... cornea. Intacs inserts is composed of two ...
Medicine Products: