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:12/17/2014)... LOS ANGELES , Dec. 17, 2014 /PRNewswire/ ... that the US Patent and Trademark Office (USPTO) ... candidate ICT-107, a dendritic cell-based immunotherapeutic vaccine targeting ... glioblastoma. The claims of US Patent No. 8,871,211, ... treating neural cancer by administering a dendritic cell ...
(Date:12/17/2014)... PCCA received the Autism Hope Alliance,s ... program seal for best practices in meeting needs ... practices, materials and goods that meet strict criteria ... affected by autism often have unique physical or ... found in food and medicine – for instance ...
(Date:12/15/2014)... 12, 2014 Research and Markets ( ... "Inferior Vena Cava (IVC) Filters - Global Trends, Estimates ... http://photos.prnewswire.com/prnh/20130307/600769 Global ... reach US$435 million by 2016. The North ... the global value while Europe ...
Breaking Medicine Technology:ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 2Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 3Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 2Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 3Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 4
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... , ROCKFORD, Mich., Aug. 31 Pediatric Wildlife ... provides the answer to an age-old problem for doctors, nurses ... http://www.point-o-care.com/desk.php#peds , , Constantly in ... professionals have long relied on bulky rolling computer tables to ...
... , , , OAKLAND, ... of training, conditioning and habits that keep mind, body and ... more balanced and flowing lifestyle is a challenge. The Breema ... and feelings to revitalize themselves, regardless of what challenges they ...
... , MINNEAPOLIS, Aug. 31 VNA ... anniversary, announced that it has entered into a business relationship ... and services to patients with chronic diseases. Cardiocom, the ... service provider of award-winning telehealth solutions. , , ...
... , NEWPORT BEACH, Calif., Aug. 31 Medical ... politicians scrambling to come up with a workable solution, Americans face ... with double-digit rate hikes. Is there any hope for hard-working Americans ... , Getting and keeping Americans healthier is by far ...
... , MORGANTOWN, W.Va., Aug. ... high-tech, innovative businesses will gather in Morgantown for the ... 2. The event marks the first time West Virginia ... two nationally competitive U.S. Small Business Administration (SBA) programs ...
... SHANGHAI, Aug. 31 /PRNewswire-Asia/ -- Sundia MediTech ... China, announced today that,it received the Highest Growth ... The award was announced at the 10th anniversary ... Tong Xu, Sundia,s Vice President,for Process Chemistry and ...
Cached Medicine News:Health News:Foldaway Pediatric Point of Care Table Provides Efficient Work Surface Without Compromising Space 2Health News:The Breema Center Presents Its Fall Week-Long Intensive on Giving and Receiving Breema Bodywork 2Health News:VNA of Hanover & Spring Grove Selects Cardiocom Telehealth Technology as Its New Telehealth Provider 2Health News:New Book on Meditation Offers a Hands-on Solution to Americans' Health Care Crisis 2Health News:Innovative Research and Technology Transfer Conference to Be Held in West Virginia for First Time Ever 2Health News:Innovative Research and Technology Transfer Conference to Be Held in West Virginia for First Time Ever 3Health News:Sundia Receives the Highest Growth Potential Award from Zhangjiang 2
... lathing techniques, intrinsically permeable polymers and advanced ... thickness of just 0.08 across all minus ... lenses maintain a 30% decrease in center ... eliminates stress points to reduce the chance ...
An easy-to-fit RGP daily wear lens with a unique bi-aspheric back surface design that provides excellent patient comfort and adaptation. Boston Envision contact lenses are an ideal alternative for vi...
Ophthalmic surgery stretcher. Designed for exceptional surgeon access, ideal for either superior or temporal approach....
... developed to stain intraocular membranes in vitreoretinal ... By injecting Membraneblue in an air-filled vitreous ... diluting the dye. After removal of all ... membranes can easily be distinguished from the ...
Medicine Products: