Navigation Links
Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
Date:8/19/2007

LEXINGTON, Mass., Aug. 17 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for VALSTAR(R). VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder.

VALSTAR was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus solved the impurity issue and submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007. The FDA approvable letter was in response to this chemistry supplement.

In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.

"VALSTAR offers an effective alternative for bladder cancer patients who have failed BCG therapy and are not candidates for immediate cystectomy," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process related investigations. We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re- introduction."

About VALSTAR(R)

VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

In clinical tria
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3 4

Related biology technology :

1. Medical College receives $377K to study brain disease
2. Lucigen receives $750K grant to boost biofuel yields
3. Medical College receives $1.4M cancer grant
4. Wisconsin biotech firm receives $107K NIH grant
5. InvivoSciences receives NIH grant for heart technology
6. Medical College receives $11 million grant to study high blood pressure
7. Madison business receives $115,000 of new state biofuels funding
8. Superior receives funds for technical training
9. UWM receives state funding for plastics research
10. GEs Centricity EHR receives federal certification
11. WHIE receives state eHealth Initiative contract
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)...  Next month, executives from clinical trial marketing firm BBK ... with Patient-Centered Clinical Trials 2014 , to be held ... , September 4-5. Patient recruitment experts Bonnie A. Brescia ... will share insights on the benefits of employing an effective ... from media to mobile apps – can be used to ...
(Date:8/28/2014)... Fla. Exciting new work by a Florida State ... system that can take your temperature, emit white light, ... And, the molecule looks like a butterfly. , Biwu ... Biomedical Engineering in the FAMU-FSU College of Engineering, created ... but has continued to discover that his creation has ...
(Date:8/28/2014)... 28, 2014 PrimeSource Building Products, ... selected SoundConnect to support their communication ... audio and web conferencing platform GlobalMeet powered by ... employees’ needs. SoundConnect delivers award winning “results ... Building Products will be utilizing GlobalMeet powered ...
(Date:8/27/2014)... TX (PRWEB) August 27, 2014 Green ... million in Series B funding and secured Otter Capital ... investment capital will accelerate commercialization of GGI’s Agriplier™ technology, ... crop types. , “Since our first meeting, we ... to the biological product space,” said Alan Sobba, President ...
Breaking Biology Technology:BBK Worldwide Leads Sessions at Key September Events 2Novel 'butterfly' molecule could build new sensors, photoenergy conversion devices 2PrimeSource Chooses SoundConnect as Collaboration Provider 2Green & Grow Inc. Secures $6M Series B Funding from Otter Capital 2Green & Grow Inc. Secures $6M Series B Funding from Otter Capital 3
... , , OMAHA, Neb., Aug. 12 Transgenomic Inc. (OTC Bulletin ... Transgenomic Inc. Second Quarter 2009 Earnings Release, ... Wednesday, August 12, 2009 @ 5:00 p.m. Eastern, Where: http://www.transgenomic.com/events.asp?id=6 , ... to the web at the, ...
... , SAN DIEGO, Aug. 12 Imagenetix, ... second study conducted on its proprietary compound, 1-TDC, for the treatment ... University, Department of Periodontology and Oral Biology, led the investigative team. ... of Periodontology and is also available online at: ...
... ATLANTA, Aug. 12 CryoLife, Inc., (NYSE: ... cardiovascular tissue processing company, today announced that it has ... Administration (FDA) for its CryoPatch((R)) SG pulmonary human cardiac ... SynerGraft technology designed to remove allogeneic donor cells and ...
Cached Biology Technology:Reminder: Transgenomic Inc. Announces Second Quarter 2009 Earnings Release Conference Call Webcast 2Boston University Periodontal Study on Imagenetix Compound Published in The Journal of Periodontology 2Boston University Periodontal Study on Imagenetix Compound Published in The Journal of Periodontology 3CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material 2CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material 3CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material 4
(Date:8/28/2014)... mobile app called TX Invasives is now available from ... of Texas at Austin for identifying harmful non-native plant, ... species in the United States cause about $137 billion ... agricultural crops, clog waterways, kill native plants and more. ... app for reporting where invasive species occur, we,re more ...
(Date:8/28/2014)... than traditional cigarettes, but still release toxins into ... USC. , Scientists studying secondhand smoke from e-cigarettes ... harmful particles, with close-to-zero exposure to organic carcinogens. ... in second-hand e-cigarette smoke were found to be ... levels of polycyclic aromatic hydrocarbons cancer-causing organic ...
(Date:8/28/2014)... support of peer groups and clinicians is critical ... to recent University of Georgia research. , A ... County area determined that role models for successful ... of infants. , "Mothers who received that support ... said study co-author Alex Anderson, an associate professor ...
Breaking Biology News(10 mins):Mobile app makes ID of harmful plants, insects in Texas a snap 2Second-hand e-cig smoke compared to regular cigarette smoke 2Breastfeeding study shows need for effective peer counseling programs 2
... highly exposed to common environmental chemicals - polyfluoroalkyl compounds ... and larger at 20 months of age, according to ... Health published online in the August 30 edition of ... in the production of fluoropolymers and are found widely ...
... leading a four-year federal research effort to evaluate freshwater ... recommendations on what can be done to make the ... population growth and the effects of climate change over ... and the University of Georgia are also part of ...
... their condition involves much more than adhering to a ... entails carefully monitoring the ongoing toll this disease takes ... diagnostic tool created by Columbia University researchers and reported ... Biomedical Optics Express may soon make it easier ...
Cached Biology News:Chemical exposure in the womb from household items may contribute to obesity 2NC State leads national effort to evaluate fresh water sustainability in the southern US 2Shedding new light on one of diabetes' most dangerous complications 2
Trop-2 Purified Anti-Human clone 162-46, Isotype Mouse IgG 1 , 100 µg Consult technical datasheet for details....
... fosmid (40kb), and large plasmid insert (10-20kb) ... BAC vector. On command 20-50 fold copy ... DNA purification. Available with blue-white screening (pEZ ... the highest insert stability. Kits include electrocompetent ...
... Adapted to Sf-900 ... were isolated from Spodoptera ... insect cells (1). The ... to serum-free suspension culture ...
... (100+kb), fosmid (40kb), and large plasmid insert ... othe BAC vector. On command 20-50 fold ... recombinant DNA purification. Available with blue-white screening ... for the highest insert stability. Kits include ...
Biology Products: