Navigation Links
Endo Pharmaceuticals Completes Next Step in Regulatory Process for FORTESTA™ for Men With Low Testosterone
Date:7/1/2010

CHADDS FORD, Pa., July 1 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel.  The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.

"We are optimistic that our expeditious and careful response to the FDA's requests will lead to the agency's approval of FORTESTA," said Julie McHugh, chief operating officer, Endo Pharmaceuticals. "We are committed to making this testosterone gel formula available as soon as possible and will continue to work closely with the FDA toward our goal of making this product available for the treatment of low testosterone in men."

ProStrakan Group plc submitted the NDA for FORTESTA to the FDA in April 2009, and Endo signed an agreement with ProStrakan in August 2009 to acquire exclusive U.S. rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside of the U.S. The principal content of the re-submission is a re-analysis of the primary variable (testosterone levels) in the original pivotal study.  This re-analysis has confirmed the reliability of the original conclusions of the study. In addition, Endo
'/>"/>

SOURCE Endo Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... DALLAS , Jan. 15, 2014 /PRNewswire-iReach/ -- ChinaMarketResearchReports.com ... to its store . (Photo: ... consumption upgrade and policy support, China,s ... the years, with total market size rising from 3.28 ...
(Date:1/15/2014)... the leading health care supply chain expertise, analytics and ... national contracts that expand its portfolio to provide hospital ... These include manufacturer product and service agreements, as well ... IT consulting support. New Novation agreements ...
(Date:1/15/2014)... BreedIT Corp (OTC: BRDT), through its Israeli ... sophisticated agro-breeding solutions for plant breeders and researchers, today ... of directors appointed chemistry and pharmaceutical industry expert Dr. ... the board. From 1975 to 2012, Dr. ...
Breaking Medicine Technology:Orthopedic Instrument Industry in China Markets Forecast to 2015 2Orthopedic Instrument Industry in China Markets Forecast to 2015 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3
(Date:4/24/2014)... is better to give than to receive at least ... study suggests. , The study found that 15- and 16-year-olds ... money to family members, are less likely to become depressed ... or keeping the money for themselves. , The researchers detail ... of Sciences . , The study focused on the ventral ...
(Date:4/24/2014)... Ore. An Oregon State University researcher has found ... of the symptoms of autism spectrum disorder in very ... be the first to show a direct relationship between ... fine and gross motor skills should be included in ... MacDonald, an assistant professor in OSU,s College of Public ...
(Date:4/24/2014)... led by a scientist at the University of York ... in the development of the nervous system may also ... cancer., A research team, led by Dr Will ... of Biology at York, has studied how voltage-gated sodium ... channels are found in the membranes of excitable cells, ...
(Date:4/23/2014)... Pregnant immigrants from Sub-Saharan Africa, Latin America ... pregnancy, according to new research from St. Michael,s ... British Journal of Obstetrics and Gynaecology , ... among immigrants and native-born women in six high-immigration ... Spain (Catalonia and Valencia) and the United States ...
(Date:4/23/2014)... director at the National Institute of Arthritis and Musculoskeletal ... recipient of the Ross Prize in Molecular Medicine, conferred ... Medicine . The award will be given on June ... Manhattan, followed by scientific presentations by Dr. O,Shea and ... Institutes of Health. , The award, which includes a ...
Breaking Medicine News(10 mins):Health News:Study: Altruistic adolescents less likely to become depressed 2Health News:Motor skill deficiencies linked to autism severity in new research 2Health News:Breast cancer replicates brain development process 2Health News:Pregnancy complications may be more common in immigrants from certain regions 2Health News:NIH scientist to receive Ross Prize in Molecular Medicine 2
... Civility Mutual, based in,Santa Fe, New Mexico, launches ... offer education, training and CMEs for physician - ... tools and assessments their residents need to fulfill ... "Civility in health care begins with effective ...
... in materials such as paints, printing and dry ... and is thought to damage the central nervous ... attention and psychomotor function, frequently persists even after ... chronic solvent-induced encephalopathy (CSE). Although CSE is an ...
... profession employs more than 786,000 workers, CHICAGO, ... announced the release of its updated statistical map ... 2006" that details how,many employees, broken down into ... dental profession. The map also provides figures for ...
... Ala. -- Laboratory studies by University of Alabama ... investigational drug triphendiol (NV-196) causes cell death in ... tumor growth and sensitizes tumors to chemotherapy treatments. ... Ewan Tytler, Ph.D., assistant professor in the UAB ...
... becomes practical for treating human diseases, researchers must master ... at The Childrens Hospital of Philadelphia have advanced delivery ... bind to a variety of gene therapy vectors and ... genes at a disease site. , In an animal ...
... small business health,initiative but urges strengthened pre-existing ... The National Patient,Advocate Foundation (NPAF) today endorsed ... (SHOP), but called for stronger protections,to protect ... NPAF CEO and President Nancy Davenport-Ennis, "The ...
Cached Medicine News:Health News:New Health Care Company to Offer Training and CMEs on Physician - Patient Communications and Helps Fulfill ACGME Requirements 2Health News:Disturbances in brain circuitry linked to chronic exposure to solvents 2Health News:Academy of General Dentistry Releases Updated Employment Statistical Map 2Health News:UAB study shows investigational drug may treat biliary cancers 2Health News:In blood vessel stents, innovative materials allow better control, delivery of gene therapy 2Health News:In blood vessel stents, innovative materials allow better control, delivery of gene therapy 3Health News:Small Businesses and the Self-Employed Need Stronger Coverage Protections for Pre-Existing Conditions 2
... demanding smaller, higher performing systems specifically ... operational challenges. The new Philips HD11 ... for superb High Definition performance; elegant ... and a versatile suite of applications ...
... Ophthalmics introduces Tear Pool punctum plugs. Tear Pool ... silicone resin with no additives via a precision ... durometer rating, which is designed to facilitate insertion ... maintains its position in the punctum. The cap ...
The Cardiff Acuity Test is designed specifically for,acuity measurement in children aged 1 to 3 years. The,test is also helpful with other age groups with,intellectual impairment, dementia, hea...
... be the world wide sole distributor of ... from conventional drug eluting stents, the CONOR ... eluting stent designed to provide advanced drug ... release profiles to be tailored to optimize ...
Medicine Products: