Navigation Links
FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
Date:3/12/2009

CHADDS FORD, Pa., March 12 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission to the new drug application for NEBIDO(R) (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. FDA is targeting September 2, 2009 as the action date for a decision on this application.

Endo's president and CEO, David Holveck, stated: "We are pleased with the FDA's action and congratulate the NEBIDO development team on reaching this milestone. We look forward to receiving the FDA's decision on the NEBIDO marketing application in September."

About NEBIDO

NEBIDO is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO was licensed by BayerSchering Pharma AG to Indevus Pharmaceuticals, a majority interest in which Endo acquired earlier this year. If approved, NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. NEBIDO is currently marketed by BayerSchering and its partners in Europe and other territories.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, musc
'/>"/>

SOURCE Endo Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
2. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
3. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
4. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
7. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
8. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
9. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
10. CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation
11. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... Investor-Edge has initiated coverage on the ... Lilly and Company (NYSE: LLY ), Nektar Therapeutics ... ), and Novartis AG (NYSE: NVS ). Free ... http://investor-edge.com/register . On Friday, December 12, 2014, the ... Industrial Average lost 1.79%, to finish the day at 17,280.83, ...
(Date:12/15/2014)... and BOSTON , December ... leading GPCR structure-guided drug discovery and development company, is ... in the United States relating ... these patents in the US significantly strengthens the global ... major pharmaceutical markets. The suite of patents ...
(Date:12/13/2014)... , Dec. 12, 2014 HudsonAlpha Institute ... HiSeq X Ten sequencing system manufactured by Illumina, ... to produce and analyze genomic data faster and ... the Institute,s commitment to research programs for genomics ... X Ten provides unprecedented capacity, speed and accuracy ...
Breaking Medicine Technology:Analysts View on Pharma Equities - Zogenix, Eli Lilly, Nektar Therapeutics, Sanofi, and Novartis 2Analysts View on Pharma Equities - Zogenix, Eli Lilly, Nektar Therapeutics, Sanofi, and Novartis 3Analysts View on Pharma Equities - Zogenix, Eli Lilly, Nektar Therapeutics, Sanofi, and Novartis 4Analysts View on Pharma Equities - Zogenix, Eli Lilly, Nektar Therapeutics, Sanofi, and Novartis 5Heptares Extends Global Patent Protection for GPCR-Focused Drug Discovery Platform With Grant of Core Patents in the United States 2HudsonAlpha announces purchase of Illumina HiSeq X Ten sequencing system 2HudsonAlpha announces purchase of Illumina HiSeq X Ten sequencing system 3
... 4 NovaRx Corporation announced today the appointment of ... and Chief Operating Officer. Dr. Russell brings to ... discovery and a long history of success driving innovation ... experience leading entrepreneurial biotechnology companies developing pioneering new technologies. ...
... - Tasigna front-line data demonstrating potential in newly diagnosed patients with ... sessions at ASH , , - ... by significantly reducing toxic iron that can damage key organs , ... major independent breast cancer trial at SABCS to report on optimal ...
Cached Medicine Technology:NovaRx Appoints Industry Veteran as President and COO 2NovaRx Appoints Industry Veteran as President and COO 3More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 2More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 3More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 5More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 6More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 7More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 8More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 9More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 10More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 11More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 12More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 13More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 14More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 15More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 16More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 17More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 18More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 19More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 20More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 21More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 22
(Date:12/15/2014)... December 15, 2014 The increase in prevalence ... of the main factors which is contributing to the growth ... the diagnosis and treatment of hearing loss and balance disorders ... three parts - microphone, speaker and amplifier. The global market ... of 6.01% during the period from 2014 to 2019. Some ...
(Date:12/15/2014)... (PRWEB) December 15, 2014 Emergo Group, ... in 26 countries in North and South America, Europe, ... responses from industry participants for its 2015 Medical Device ... order to identify upcoming business and market trends as ... , The survey targets areas including:, , ...
(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 ...
(Date:12/15/2014)... (PRWEB) December 15, 2014 Kenmode Precision ... the firm as Director of Quality Assurance. He ... quality systems, processes and certifications for manufacturers in the ... posts of Corporate Quality Manager at Sonoco Products Company ... at NetCom, Inc., and Quality Assurance Manager for Prince ...
(Date:12/15/2014)... Metal drilling machines have ... This score indicates that neither buyers nor suppliers have ... have been raising the price of metal drilling machines ... rising demand,” according to IBISWorld business research analyst, Jeffrey ... During the past three years, high price driver volatility ...
Breaking Medicine News(10 mins):Health News:Audiological Devices Market 2019 Demand for Esthetic Hearing Aids Drives the Growth, Says a Report at ReportsnReports.com 2Health News:Audiological Devices Market 2019 Demand for Esthetic Hearing Aids Drives the Growth, Says a Report at ReportsnReports.com 3Health News:Audiological Devices Market 2019 Demand for Esthetic Hearing Aids Drives the Growth, Says a Report at ReportsnReports.com 4Health News:Emergo’s Annual Survey Assessing the State of the Medical Device Industry Now Open 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 3Health News:Kenmode Precision Metal Stamping Appoints Abid Rashid as Director of Quality Assurance 2Health News:Metal Drilling Machines Procurement Category Market Research Report Now Available from IBISWorld 2Health News:Metal Drilling Machines Procurement Category Market Research Report Now Available from IBISWorld 3
... to excess days off, poor-quality output, study finds , , ... attention deficit hyperactivity disorder (ADHD) miss, on average, more ... to a new global reckoning of the problem. , ... worldwide have ADHD, according to survey data from the ...
... Neck, leg sites similar, but jugular should be choice for ... News) -- There,s little overall difference in infection risk if ... or an upper leg vein in critically ill patients, French ... is less likely to cause infection than the leg catheter. ...
... is not a phrase normally used to describe a ... Tel Aviv University, the chemical industry is a step ... from the School of Chemistry at Tel Aviv University ... certain steps of a complicated chain of chemical reactions ...
... With many Americans eagerly,awaiting some extra cash in their ... time to make an investment in your health. As ... Association and its,3,000 members urge you to invest your ... "What,s more important than investing in your health?" said ...
... Introduces EveryKid(TM), An Organic First For Children,s ... ... food,chemical-free nutrition is ideal to a child,s healthy growth and,development, parents ... of chemical vitamin,isolates. But today, New Chapter -- the leading producer ...
... explain why some nonsmokers contract the disease, study says , , ... increases the risk of lung cancer, even in nonsmokers, researchers ... alpha1-antitrypsin gene double someones risk of developing lung cancer, regardless ... explain why some nonsmokers develop the disease, said study author ...
Cached Medicine News:Health News:Adults With ADHD Lose 3 Weeks Worth of Work Annually 2Health News:Adults With ADHD Lose 3 Weeks Worth of Work Annually 3Health News:Dialysis Catheter Placement Makes Little Difference in Infection Risk 2Health News:1 small step for a lab science, 1 green leap for mankind 2Health News:Invest in Your Future With a Spa Visit Today 2Health News:Invest in Your Future With a Spa Visit Today 3Health News:Finally ... A Pure and Perfect Multi-Vitamin for Every Kid 2Health News:Finally ... A Pure and Perfect Multi-Vitamin for Every Kid 3Health News:Common Genetic Variant Tied to Lung Cancer Risk 2Health News:Common Genetic Variant Tied to Lung Cancer Risk 3
Inquire...
Inquire...
Inquire...
... range of 18 Ophthalmic frames created ... producted to the very hightest quality. ... lightweight Titanium and Beta Titanium models, ... of beautifully formed and innovative designs ...
Medicine Products: