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:8/22/2014)... , Aug. 22, 2014  Cannabis Science, Inc. ... formulation-based drug development and related consulting, is pleased ... international medical cannabis conference taking place at the ... , on October 22, 2014.  The multilingual ... such as researchers, health professionals, and patients, to ...
(Date:8/22/2014)... 2014  WaferGen Bio-systems, Inc. (NASDAQ: WGBS) today announced ... of common stock and warrants at a price of ... prior to deducting underwriting discounts and commissions and offering ... are immediately separable and will be issued separately.  The ... on The NASDAQ Stock Market under the ticker symbol ...
(Date:8/21/2014)... 2014  Vermillion, Inc. (NASDAQ: VRML ), ... women,s health, has appointed Holly B. Bauzon ... Ms. Bauzon has a proven track record in ... laboratory services companies. She has more than 20 years ... she held the position of Director, Lab Services Sales ...
Breaking Medicine Technology:Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 2Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 3WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 2WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 3WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 4Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2
... May 3 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX ) announced ... closes on Thursday, May 13, 2010 .  A conference call and live ... 5:00 p.m. Eastern Time to discuss the results. , ... To participate in the call, please dial 877-303-1298 (for ...
... EATONTOWN, N.J. , May 3 Osteotech, Inc. (Nasdaq: ... products for regenerative healing, announced today that the Company,s first quarter ... before the market opens on Monday, May 10, 2010 . ... webcast on Monday, May 10, 2010 , at 9:00 ...
Cached Medicine Technology:Cumberland Pharmaceuticals To Announce First Quarter 2010 Financial Results on May 13, 2010 2Osteotech Announces First Quarter 2010 Financial Results Release and Conference Call 2
(Date:8/22/2014)... “Dr. Luciana Show – Aging and Falling” is currently ... finding it challenging to stay on top of post-production tasks ... of students, so the editing of the episodes will take ... she recently entered it into the festival circuit. , ... actor/screenwriter Gregory Graham , the aging and falling show ...
(Date:8/22/2014)... the leading pan-European organisation representing medical oncology professionals, ... receiving the Society,s esteemed annual awards. The awards ... and Peter Boyle on the occasion of the ... Carsten Bokemeyer will receive the ESMO Award for ... discovery into real benefit at patient level. 1 ...
(Date:8/22/2014)... Chest pain, breathing difficulties, fainting. Each year approx. 265,000 ... of serious illness. New research from Aarhus University and ... as many as every fourth patient are ... severe symptoms that led to the acute hospitalisation., "Naturally, ... examinations at the hospital disprove that there is a ...
(Date:8/22/2014)... disease can be slowed and some of its ... found in pomegranate. Also, the painful inflammation ... Parkinson,s disease could be reduced, according to the ... of Huddersfield scientist Dr Olumayokun Olajide, who specialises ... Now, a new phase of research can explore ...
(Date:8/22/2014)... cancer Hodgkin lymphoma will be able to better understand ... risk of premature menopause with different treatments. , The ... National Cancer Institute , are based on the experience ... Wales treated for the cancer over a period of ... that women with Hodgkin lymphoma who receive certain types ...
Breaking Medicine News(10 mins):Health News:Professor Luciana Lagana Dedicates to Her CSUN Students the “Dr. Luciana Show-Aging and Falling” AOF Festival Nomination (Screening at Krikorian Monrovia Cinema on 08/25) 2Health News:Professor Luciana Lagana Dedicates to Her CSUN Students the “Dr. Luciana Show-Aging and Falling” AOF Festival Nomination (Screening at Krikorian Monrovia Cinema on 08/25) 3Health News:Professor Luciana Lagana Dedicates to Her CSUN Students the “Dr. Luciana Show-Aging and Falling” AOF Festival Nomination (Screening at Krikorian Monrovia Cinema on 08/25) 4Health News:ESMO honors outstanding oncology professionals 2Health News:ESMO honors outstanding oncology professionals 3Health News:Many patients are discharged without a diagnosis 2Health News:Research underway to create pomegranate drug to stem Alzheimer's and Parkinson's 2Health News:Scientists map risk of premature menopause after cancer treatment 2
... after an eye infection was detected in association with the ... complaints arising from Asia, US and Europe under pressure since ... to a spate of serious eye infections in Asia and ... infection had also been confirmed in Europe. Bausch & Lomb, ...
... of the jungles not by the armed forces, but by ... said a malaria epidemic sweeping Assam and its adjoining areas ... Asom (ULFA) to come out of their hideouts. ... suspect ULFA cadres hit by malaria have been admitted for ...
... High Court has demanded an explanation from the medical superintendent ... suffering from cancer got inflicted with AIDS after undergoing blood ... explanation on why the relevant documents were not being made ... ruled that the blood transfusion was the business of the ...
... the shake-up of the out of hours health care system in ... costs//. ,The public accounts committee claimed that the new ... not met many key targets. ,In 2004 most GPs ... after which PCTs took over in 90% of cases. ...
... Minister, Andy Kerr has finally admitted that the centralization ... travellong distances// to receive health care. The limitations of ... evident. , Patients and their relatives considered ... bus services were inadequate. ,The problem of ...
... new study conducted to analyze the risk attitudes and ... out to be risk takers compared to women// who ... Such protective measures include, drinking in the company of ... and restricting the amount of money spent on drinking. ...
Cached Medicine News:Health News:Malaria Epidemic Forces Assam Rebels Out Of The Jungle 2Health News:Risk Attitudes And Consequences Of College Drinking 2
Eberbach's 2800 Series Micro Slide Cabinets provide safe, short-term and long-term, storage of prepared slides which can easily be indexed for retrieval. Cabinets are available in (2) two styles, a U...
Compact storage cabinets for 35 mm slides....
Fisherbrand* Micro Slide Cabinet is made of heavy gauge, reinforced steel....
Slide Sorters for sorting and viewing 5 cm x 5 cm (2 inches x 2 inches) color slides....
Medicine Products: