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NEBIDO in Medical News

Men with Low Testosterone See Multiple Doctors Before Being Diagnosed; Many Dissatisfied with Current Treatment Options

...currently is pending U.S. Food and Drug Administration approval. Testosterone undecanoate was first approved in Europe in 2003 and is now marketed as nebido in more than 80 countries by Bayer Schering Pharma AG. ABOUT HYPOGONADISM Hypogonadism, also known as low testosterone, is a common yet la...

Testosterone Undecanoate Achieves and Maintains Normal Testosterone Levels in Hypogonadal Men With Five Injections Per Year, New Data Show

...thin the normal range over the 21-month study, and nebido was generally well tolerated. The long-term clini...rmal range throughout the 21-month study, and that nebido was generally well tolerated. nebido is currently under review at the U.S. Food and Dru...

Indevus Pharmaceuticals Announces Definitive Merger Agreement With Endo Pharmaceuticals

... upon achievement of certain milestones related to nebido (R) (in development for hypogonadism) and the octr...ant interest in the downstream value creation from nebido and the octreotide implant. "Our employees, w...r. "Our sales force, Cranbury operations, and the nebido and Octreotide R&D teams are expected to play ...

Endo Pharmaceuticals to Acquire Indevus Pharmaceuticals

...signed for easy, in-office physician insertion under local anesthesia. nebido is a novel, long-acting injectable testosterone depot being developed for t...to support regulatory review of the company's pending application to market nebido as the first long-acting testosterone preparation available in the United S...

Indevus Pharmaceuticals Announces Third Quarter Fiscal 2008 Financial Results

...cipate being able to discuss our future plans with nebido in the coming months. "Our portfolio of marketed...gn our expense structure with the realities of the nebido delay," stated Dr. Cooper. "Our new operating plan...acement therapies. Indevus acquired U.S. rights to nebido from Bayer Schering Pharma AG, Germany in July 200...

Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status

...aneous post-marketing adverse event reports of the nebido 1000 mg (4ml) dose. In the Indevus U.S. clinical t...orts on patients having received the 1000 mg (4ml) nebido dose, FDA has asked for new data to more precisely... the FDA is taking regarding the safety profile of nebido given the large European experience. Rare coughing...

FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus

...n Drug User Fee Act (PDUFA) target action date for nebido is June 27, 2008. The NDA was submitted to the FDA...nce from over 260,000 injections of NEBIDO. About nebido NEBIDO(R) is a long-acting depot preparation of t... developed for the treatment of male hypogonadism. nebido is expected to be the first three-month testostero...
NEBIDO in Medical Technology

Indevus Reports Positive Data From Phase III NEBIDO Trial

Compound Achieves All Key Endpoints for Both Efficacy and Safety LEXINGTON, Mass., June 07, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced final results from its Phase III pharmacokinetic trial for NEBIDO (testosterone undecanoate), a long- acting injectable testoster...

FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

...pleased with the FDA's action and congratulate the nebido development team on reaching this milestone. We l...ook forward to receiving the FDA's decision on the nebido marketing application in September." About nebido ...

Indevus Presents Successful Phase III NEBIDO(R) Data at American Urological Association

...riteria. Patients received injections of 750 mg of nebido at baseline, week 4, and week 14 of the study, and... developed for the treatment of male hypogonadism. nebido is expected to be the first long-acting testostero...sterone therapies. Indevus acquired U.S. rights to nebido from Bayer Schering Pharma AG, Germany in July 200...

Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)

... Company Files Additional Data to the nebido NDA PDUFA Date Expected to Remain Jun...al positive results from its Phase III program for nebido (testosterone undecanoate), a long-acting injectab...n Drug User Fee Act (PDUFA) target action date for nebido will remain June 27, 2008. The dosing regimen fo...

Indevus Announces Submission of New Drug Application

... Seeking Approval for nebido to Treat Male Hypogonadism LEXINGTON, Mass., Aug...ny) which has formed the basis for the approval of nebido in over 75 countries to date. The U.S. testostero...,000 injections of NEBIDO. "The submission of the nebido NDA is a very important milestone for the Company,...
NEBIDO in Biological Technology

Indevus Pharmaceuticals Announces Fiscal 2008 Year End and Fourth Quarter Results

...ghts During the past year, the Company achieved a number of important milestones, including: Clinical Development -- Results From nebido Phase III Trial Shows 94 Percent of Men Maintained Normal Testosterone Levels Throughout Treatment -- Results From Two-Year Study Confirmin...

Indevus and FDA Agree on Path Forward for NEBIDO(R)

...rge, simple post- marketing study of the safety of nebido in approximately 10,000 patients. "We are very p...uming approval, we will be in a position to launch nebido with our sales force in the fourth quarter of cale...osterone therapy and we expect the introduction of nebido to have a significant positive impact on the Compa...

Indevus Receives Approvable Letter from FDA for NEBIDO(R)

...any Announces Revised Operating Plan to Respond to nebido Delay LEXINGTON, Mass., June 30 /PRNewswire-Firs...mediately following the intramuscular injection of nebido 1000 mg, 4 cc injection volume, (versus the 750 mg...fainting. In the Company's U.S. clinical trials of nebido 750 mg (3 cc injection volume), the proposed dose ...
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