Navigation Links
Indevus Announces Submission of New Drug Application
Date:8/28/2007

Seeking Approval for NEBIDO to Treat Male Hypogonadism

LEXINGTON, Mass., Aug. 28 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO(R) (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism. Each 1000 mg injection of NEBIDO would only need to be provided once every 12 weeks, as compared to the current injectable therapies which typically require an injection every two to three weeks.

The NDA submission follows the June 2007 announcement of positive results from the Company's Phase III pharmacokinetic trial for NEBIDO. In addition to the data from this U.S. trial, the NDA includes the results of the European clinical trials database (originally generated by the Company's partner, Bayer Schering Pharma AG, Germany) which has formed the basis for the approval of NEBIDO in over 75 countries to date.

The U.S. testosterone therapy market is currently estimated to be in excess of $550 million. Of the approximately 340,000 men currently receiving therapy, approximately 130,000 utilize the existing injectable therapies that must be given every two to three weeks.

The NDA contains data from six clinical studies in which over 400 patients received at least one dose of NEBIDO, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of NEBIDO have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through J
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Indevus Announces Presentation of Pagoclone Data at 47th Annual New Clinical Drug Evaluation Unit Meeting
2. Indevus Reports Positive Data From Phase III NEBIDO Trial
3. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
4. Sygnis Pharma AG announces date for presentation of clinical results
5. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
7. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
8. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
9. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
10. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Most osteoporosis patients want a choice in the ... sponsored by Mission Pharmacal Company. The survey, conducted by ... support community, revealed that 74 percent of osteoporosis patients ... form other than a pill or a tablet. ...
(Date:1/15/2014)... 2014  Celsion Corporation (the "Company") (NASDAQ: CLSN ... institutional investors to purchase an aggregate of approximately $15 ... registered direct offering, led by a dedicated health care ... agreements with these investors pursuant to which the Company ...
(Date:1/15/2014)... 15, 2014  Manufacturers, suppliers and distributors of innovative ... protect their most important business assets, intellectual property ... Because of the highly-competitive nature of ... of the most litigious industry sectors of cases ...
Breaking Medicine Technology:Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Intellectual Property Insurance for Medical-related Products and Services 2
... NANJING, China, Jan. 13, 2011 /PRNewswire-Asia/ -- Simcere ... SCR ), a leading pharmaceutical company specializing ... and proprietary pharmaceuticals in China, today announced the ... for personal reasons, effective January 15, 2011. Simcere,s ...
... the third largest medical transcription service, speech recognition technology and ... has received the Best in KLAS Award for Transcription ... KLAS Awards: Software & Professional Services report. In addition ... was also rated No. 1 in their category for professional ...
Cached Medicine Technology:Simcere Pharmaceutical Group Announces Resignation of CFO Frank Zhao 2Webmedx Named Best in KLAS and Ranked #1 Transcription Services Vendor for Second Year in a Row 2Webmedx Named Best in KLAS and Ranked #1 Transcription Services Vendor for Second Year in a Row 3
(Date:7/9/2014)... Allergy and Infectious Diseases (NIAID), part of the ... clinical trial of CRS3123, an investigational oral antibiotic ... C. difficile ) infection. CRS3123 (previously known as ... difficile growth while sparing normal intestinal bacteria. , ... 30 healthy men and women ages 18 to ...
(Date:7/9/2014)... A retrospective study conducted by researchers at Tufts ... among adults with intellectual and developmental disabilities, the likelihood ... receiving dental care increased. The findings, published in the ... may help improve interventions designed to address the oral ... researchers reviewed the dental records of 107 patients at ...
(Date:7/9/2014)... linking older age with kidney and heart disease have ... among older adults. However, in the first study to ... School of Medicine at the University of Pennsylvania report ... similar life expectancy and cardiovascular health as very healthy ... light of the ever increasing organ transplant waitlists, the ...
(Date:7/9/2014)... 9, 2014 A study published in the scientific ... and Robert Bonin, two researchers at Universit Laval, reveals ... a new method that involves rekindling pain so that ... to novel means to alleviate chronic pain. , The ... and Institut universitaire en sant mentale de Qubec (IUSMQ) ...
(Date:7/9/2014)... Molecular microbiologists from the Keck School of Medicine ... discovered that mice lacking a specific component of ... a potentially fatal complication of infection. The discovery ... help reduce inflammation in human autoimmune and hyper-inflammatory ... diabetes. , The study was published online on ...
Breaking Medicine News(10 mins):Health News:NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection 2Health News:Adults with special needs see gains, challenges with long term oral care 2Health News:Adults with special needs see gains, challenges with long term oral care 3Health News:Penn study finds living kidney donation does not increase risk of death or heart disease for older 2Health News:Discovery of a new means to erase pain 2
... Sept. 26 Tim Dupler, the former,President of Ronco ... LLC to design and implement a new international direct ... Board: NNTN).,During his tenure as President of Ronco, the ... in less than one year. Fred Zeidman, Chairman ...
... ... Channel Partner, ... G-Trainer anti-gravity treadmill, today announced advisor,relationships with world-renowned industry experts ... Alter-G,s anti-gravity treadmill, the G-Trainer, enables users to,reduce their effective ...
... SANTA BARBARA, Calif., Sept. 25 September,26th marks ... is a,lethal, extremely painful cancer in which membrane ... resulting tumor thickens and hardens,crushing the lungs and ... even breathing is excruciating, or invading the heart, ...
... Fattah votes in favor of health insurance for low-income ... ... Congressman Chaka,Fattah (D-PA) joined with a bi-partisan coalition of his colleagues today,and ... "For years I have been a supporter of both The Children,s ...
... Despite strong evidence that cardiac rehabilitation reduces disability and ... rehabilitation services after a heart attack or coronary bypass ... of the American Heart Association. , We need to ... because it is used very little by patients who ...
... Sept. 25 Gentiva Health,Services, Inc. (Nasdaq: ... health and related services, today announced that it ... Securities and,Exchange Commission (SEC) for the periodic offering ... securities, preferred stock, common stock and warrants,after the ...
Cached Medicine News:Health News:Former Ronco President Tim Dupler Signs International Direct Sales and Marketing Contract with Natural Nutrition 2Health News:Alter-G Forging New Relationships 2Health News:Alter-G Forging New Relationships 3Health News:Meso Awareness Day, September 26th: 2Health News:Meso Awareness Day, September 26th: 3Health News:Rehabilitation significantly underused after heart attack and bypass surgery 2Health News:Rehabilitation significantly underused after heart attack and bypass surgery 3Health News:Gentiva(R) Health Services Files Universal Shelf Registration Statement 2Health News:Gentiva(R) Health Services Files Universal Shelf Registration Statement 3
... ExTOL systems feature your choice of ... electrocardiographs, an easy-to-operate monitor and the ... exercise stress testing systems also feature ... point, pre-programmed or custom protocols, and ...
... w/ Remote/Controller. Includes Full Range ... Children. Multiple 20/20 slides. Polarized ... allows you to customize your slide choices. ... with Long Life. Variety of mounting options. ...
... Ultimate in Stability. ... stabilizer features superior arm ... in the clamp/turret mechanism. ... features the ultimate flexibility ...
... leader in beating heart bypass, comes the ... NS device is the first leap in ... of surgical revascularization.,The Starfish NS Heart Positioner ... Small Thoracotomy (MVST) procedure without CPB and ...
Medicine Products: