Navigation Links
Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism
Date:9/2/2009

CHADDS FORD, Pa., Sept. 2 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the agency has extended its review period for its long-acting testosterone undecanoate injection for men diagnosed with hypogonadism, from Sept. 2, 2009 to Dec. 2, 2009.

While the FDA has not requested additional data, the agency has informed the company that it needs more time to complete its review of the application and finalize the risk evaluation and mitigation strategy (REMS) for this product.

"Our goal is to make this significant new treatment option available to the millions of men in the U.S. suffering from low testosterone," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "We believe our application fully supports the approval of this therapy, which will be an important step in filling a gap in testosterone therapy and improving patient care."

Endo Pharmaceuticals' long-acting testosterone undecanoate, known as Nebido(R) outside the U.S., was licensed by Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company that Endo acquired earlier this year. Nebido, discovered and developed by Bayer Schering Pharma AG, Germany, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.

About Hypogonadism

Hypogonadism, or low testosterone, is a common yet largely under-recognized and under-treated condition. An estimated 13.8 million American men have testosterone levels characterized as below normal (testosterone <300ng/dl). Yet despite this high prevalence, only about 9 percent of men with low testosterone are treate
'/>"/>

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

Page: 1 2 3 4

Related medicine news :

1. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
4. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
5. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
6. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
8. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
9. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
10. Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
11. Class Settlement Could Result in Considerable Savings for Certain Consumers of Prescription Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/30/2014)... 31 August 2014: A new batteryless cardiac pacemaker ... heart motion was presented at ESC Congress 2014 ... device does not require battery replacement. , Mr ... Group at ARTORG, University of Bern, Switzerland, said: ... implants. Once they reach a critically low energy ...
(Date:8/30/2014)... (PRWEB) August 31, 2014 According to the ... step by step holistic system for skin health. It seems ... already been tried by more than 138,000 patients from all ... Mike Walden, who says that this method will not only ... clear skin. , What makes this program unique among ...
(Date:8/30/2014)... (PRWEB) August 31, 2014 In a world ... dog’ approach, Karma Web Group, LLC launches a game app ... Android the newly launched Ultimate Karma app is a colorful ... new levels of play, the game pulls double-duty by teaching ... same time. , Designed to reward gamers for consistently taking ...
(Date:8/30/2014)... NY (PRWEB) August 31, 2014 This ... and fastest growing union in New York State and ... middle-class healthcare jobs and the best quality of care ... , In recent years, thousands of healthcare workers in ... and their families by becoming members of the healthcare ...
(Date:8/30/2014)... 31, 2014 Atlanta based automotive group ... help raise money and awareness for ALS by participating ... Managers, staff, and even Vice President Jimmy Ellis all ... and can be viewed on their Youtube page; ... challenge, general managers and staff also took the opportunity ...
Breaking Medicine News(10 mins):Health News:Batteryless cardiac pacemaker is based on automatic wristwatch 2Health News:Acne No More Review Reveals Unusual Tip to Eliminate Acne Permanently 2Health News:Newly Launched Ultimate Karma App Elicits Happiness in Players and Encourages Moral Values 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 3Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 4Health News:Jim Ellis Automotive Group Take the ALS Ice Bucket Challenge 2
... Medical Center,s Institute for Regenerative Medicine and colleagues have discovered ... how the human body regulates blood sugar levels. Reporting in ... says the protein may represent a new target for treating ... current thinking about what causes type 1 diabetes," said Bryon ...
... Journal of Clinical Oncology shows that most patients ... surgery recover an average quality of life. However, quality of ... level that remains much lower than the average population in ... that hospitals must be better at identifying this patient group. ...
... clinical research findings in peer-reviewed biomedical journals, Yale School of ... sample of trials primarily or partially funded by the National ... completing the clinical trial. These findings appear in ... which focuses on the topic of unpublished evidence. ...
... Reporter , TUESDAY, Jan. 3 (HealthDay News) -- Obese people ... risk of heart attack, stroke and death, Swedish researchers report. ... metabolic changes that occur after the surgery, such as altered ... "Bariatric surgery is associated with about 30 percent reduction ...
... News) -- Sexual satisfaction increases with age among sexually active ... don,t have sex are satisfied with their sex lives. ... planned community in the San Diego area and whose ... average age was 67 years and 63 percent of them ...
... all wounds Wound healing requires complex interactions between ... As healing progresses, the growth of new blood vessels is ... are cells that come from the bone marrow and are ... that direct their emigration from the bone marrow are unknown. ...
Cached Medicine News:Health News:Researchers discover protein that may represent new target for treating type 1 diabetes 2Health News:Impaired quality of life: A warning signal after oesophageal cancer surgery 2Health News:Many NIH-funded clinical trials go unpublished over 2 years after completion 2Health News:Weight Loss Surgery Linked to Fewer Heart Attacks, Deaths 2Health News:Weight Loss Surgery Linked to Fewer Heart Attacks, Deaths 3Health News:Women's Sexual Satisfaction Often Rises With Age: Study 2Health News:Preview of articles to be published Jan. 3, 2012 2Health News:Preview of articles to be published Jan. 3, 2012 3Health News:Preview of articles to be published Jan. 3, 2012 4Health News:Preview of articles to be published Jan. 3, 2012 5Health News:Preview of articles to be published Jan. 3, 2012 6Health News:Preview of articles to be published Jan. 3, 2012 7Health News:Preview of articles to be published Jan. 3, 2012 8
(Date:8/29/2014)... 2014 Does your doctor know what you,re smoking?  ... recommended marijuana to the over 112,000 currently registered patients under ... of the other roughly 20,300+ active physicians listed with the ... it – even though a poll in February 2014 showed ... have tried it. "With marijuana legalization underway, ...
(Date:8/29/2014)... Aug. 29, 2014 Diseases largely eradicated in ... ago are returning. Measles was declared eliminated in 2000, ... as of August 15—the highest incidence in 20 years. ... department declared whooping cough a problem of "epidemic ... sick and dying from these preventable diseases—in part because ...
(Date:8/29/2014)... 29, 2014  Abaxis, Inc. (NasdaqGS: ABAX ... and consumables to the medical, research and veterinary markets, ... Chief Executive Officer, will present at the CL King ... Tuesday, September 9, 2014 at 12:30 p.m. ET. The ... Hotel in New York City . ...
Breaking Medicine Technology:Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 3Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 4Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3Abaxis, Inc. to Present at CL King's 12th Annual Best Ideas Conference 2014 2
... Medicare Part D beneficiaries who enter the "donut ... previously subsidized prescription costs, are twice as likely to ... more affordable or generic medications, a new study published ... (Logo: http://photos.prnewswire.com/prnh/20090226/NE75914LOGO) The study conducted by researchers ...
... The National Association of Drug Diversion Investigators ... Responsibly to Ensure Safety) Alliance (SM) have joined Attorney ... issue in Florida – prescription drug abuse. Attorney General ... a statewide Drug Take Back Day. NADDI and the ...
Cached Medicine Technology:CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 2CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 3NADDI and the C.A.R.E.S. Alliance Join Attorney General Bondi in Fight Against Prescription Drug Abuse 2NADDI and the C.A.R.E.S. Alliance Join Attorney General Bondi in Fight Against Prescription Drug Abuse 3
Instrument necessary for insertion of Ritleng Bicanaliculus systems and of Self-Threading Monoka systems....
... For canalicular laceration or ... silicone and Stainless Steel Probe. ... Tubing securely swaged into malleable ... anchored by punctum plug: no ...
Recommended to insert plug portion of all monocanalicular intubation systems into punctum....
Skin Tone External Eyelid Weights...
Medicine Products: