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.
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.
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
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
(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
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
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
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."
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
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
NEBIDO in Biological Technology
Indevus Pharmaceuticals Announces Fiscal 2008 Year End and Fourth Quarter Results
During the past year, the Company achieved a number of important
-- 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
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
LEXINGTON, Mass., June 30 /PRNewswire-Firs...mediately following the intramuscular injection of nebido
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