Navigation Links
Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status
Date:6/4/2008

Company Expects FDA to Request Additional Safety Study Prior to Approval

LEXINGTON, Mass., June 4 /PRNewswire/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA filing for NEBIDO(R), the Company expects the FDA to formally request that the Company provide additional safety data prior to approving NEBIDO. The Company currently believes that an additional study will be required in order to supply the necessary data. The Company expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the Company expects to receive by the original June 27, 2008 PDUFA date.

The Company believes the requirement for additional data relates to a reaction immediately following the injection and is a known rare complication of oil-based depot injections. The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and may be due to improper injection technique. The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting.

The Company believes that the FDA's safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml) dose. In the Indevus U.S. clinical trials, which included a total of approximately 500 patients, there was a si
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Indevus Pharmaceuticals Licenses European Rights for VANTAS(R) to Orion Corporation
2. Indevus Pharmaceuticals Announces Retirement Plans For Its CEO and Chairman
3. Indevus To Announce First Quarter Fiscal 2008 Financial Results On Thursday, February 7, 2008
4. Indevus Pharmaceuticals To Present at RBC Capital Markets Conference
5. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
6. Indevus Pharmaceuticals to Present at Upcoming Investor Conferences
7. MAP Pharmaceuticals to Present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference
8. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the Seventh Annual Needham & Company, LLC Biotechnology and Medical Technology Conference on June 11, 2008 in New York
9. Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)
10. Amira Pharmaceuticals Achieves Milestones in FLAP Inhibitor Program With GlaxoSmithKline
11. Vion Pharmaceuticals Announces Presentation of Data from Phase III Trial of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed Acute Myelogenous Leukemia at the ASCO(R) Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/14/2014)... orphaned by HIV/AIDS in South Africa may provide insight ... behavior issues in other areas of the world, which ... that could lead to successful interventions. , A ... United Nations mentions that due to the HIV/AIDS pandemic, ... African, children are at an increased risk for mental ...
(Date:4/14/2014)... A new study shows that moderate to severe ... risk of stroke, cancer and death. , Results of ... to severe obstructive sleep apnea were four times more ... times more likely to have a stroke (HR = ... (HR = 3.4), and 2.5 times more likely to ...
(Date:4/14/2014)... Dallas study involving serious youth offenders, the answer to one ... seven years: "How long do you think you,ll live?", According ... offending over time., Author Dr. Alex Piquero said the study ... of them offend at very high rates and commit more ... much later in life offend much less., "In a lot ...
(Date:4/14/2014)... with symptoms increasing dramatically during some of the most important ... has found. , Depressive symptoms increased on average by 68 ... young men, who were around 25 years old when they ... their children. The results of the study were published April ... is the first to identify when young fathers are at ...
(Date:4/14/2014)... Lower weight babies and babies who aren,t breastfed ... risk of developing chronic inflammation and related health ... study. , "There were good reasons to hypothesize ... inflammation in adulthood," says Thomas McDade (Northwestern University), ... in the Child & Brain Development program. "It ...
Breaking Medicine News(10 mins):Health News:Researchers identify children with emotional behavior difficulties 2Health News:Researchers identify children with emotional behavior difficulties 3Health News:Study links severe sleep apnea to increased risk of stroke, cancer and death 2Health News:UT Dallas study: Youth who fail to envision future commit more crimes 2Health News:Young dads at high risk of depression, too 2Health News:Low birth weight, less breastfeeding create later health risks 2
... which has pointed out a 4% decline in healthcare expenditures ... Health and Human Service has attributed this drop - from ... 2003- to the spiraling growth in expenditures on prescription drugs, ... Agency for Healthcare Research and Quality in Health Affairs has ...
... structural protein called nestin to a particularly deadly form ... lead to earlier detection and better treatment.// ... from Dartmouth Medical School demonstrate that nestin could represent ... a highly aggressive cancer with similarities to mammary stem ...
... disease (COPD), combining a long-acting bronchodilator with an ... 35 percent.// ,Peter Kardos, M.D., of the ... am Main, Germany, and three associates treated patients ... centers across Germany. All had less than a ...
... study by UK’S Metropolitan police, stating that the establishment of ... social behavior has put the spotlight on problem gamblers. ... report: Gambling Addiction and its Treatment within the UK, have ... support and treatment for gamblers, as gambling can now ...
... many fried foods may make women infertile, says a new ... found that women with ovulation-related fertility problems //tended to eat ... of health Magazine WebMD. ,Trans fat is an ... into margarine or shortening. It is also found in foods ...
... delivered in lipid-based nanoparticles drastically reduces the number ... tumors in mice, researchers at The University of ... University of Texas Southwestern Medical Center report in ... ,Two tumor-suppressing genes given intravenously reduced cancer separately ...
Cached Medicine News:Health News:Selective Marker Found to Indicate Aggressive Form of Breast Cancer 2Health News:Selective Marker Found to Indicate Aggressive Form of Breast Cancer 3Health News:Gambling to Be Taken as a Serious Addiction, Warns BMA 2Health News:Dual Gene Therapy Suppresses Lung Cancer in Preclinical Test 2
(Date:1/15/2014)...  Research and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ) has ... Market - Global Industry Analysis, Size, Share, Growth, ... to their offering. (Logo: ... are products which are used on patients in ... and in treatment of associated gingival tissues. This ...
(Date:1/15/2014)... 2014  Celsion Corporation (the "Company") (NASDAQ: ... received commitments from institutional investors to purchase an ... common stock in an at-the-market registered direct offering, ... The Company entered into definitive purchase agreements ... agreed to sell an aggregate of 3,603,603 shares ...
(Date:1/15/2014)... , January 15, 2014 ... Ltd., the exclusive worldwide distributor of highly sophisticated agro-breeding ... on January 7, 2014, the Company,s board of directors ... Weiner as its new member of the board. ... executive positions with Teva Pharmaceutical Industries Ltd (NYSE: ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3
... Aethlon Medical, Inc. (OTC Bulletin Board: ... filtration devices to address infectious disease and cancer, ... entitled: " A Platform to Address Bioterrorism." ... at: http://www.aethlonmedical.com/knowledge-center/special-reports/ ...
... 2010 Northwestern Memorial Hospital is one ... will test whether operable lung cancer patients and their ... by hardwiring data systems to reduce medical error and ... trial co-sponsored by the Commission on Cancer and the ...
Cached Medicine Technology:'A Platform Technology to Address Bioterrorism' Released by Aethlon Medical, Inc. 2'A Platform Technology to Address Bioterrorism' Released by Aethlon Medical, Inc. 3'A Platform Technology to Address Bioterrorism' Released by Aethlon Medical, Inc. 4Lung Cancer Patients the Centerpiece for Northwestern Medicine Quality of Care Study 2Lung Cancer Patients the Centerpiece for Northwestern Medicine Quality of Care Study 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: