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:1/22/2015)... DE (PRWEB) January 22, 2015 Controlled ... Pistoia Alliance, which helps companies check the legal requirements ... to expand to China. , As their international ... are globally adopting software solutions built as a result ...
(Date:1/22/2015)... , 22 de enero de 2015  El Dr. ... su llamada a nominaciones para 2015. Este prestigioso premio ... o tiene el potencial para hacer, contribuciones destacadas para ... aceptarán hasta el 15 de marzo de 2015 a ...
(Date:1/22/2015)... , Jan. 22, 2015   GenoSpace , a precision medicine ... to enable the broad use of genomic, imaging and other ... appointment of Michelle Munson , CEO of Aspera, an ... Logo - http://photos.prnewswire.com/prnh/20150122/170713 "We ...
(Date:12/24/2014)...  United Therapeutics Corporation (NASDAQ: UTHR ) announced ... has submitted a pre-market approval application to the U.S. ... Medtronic,s SynchroMed ® II implantable drug infusion system ... Therapeutics, Remodulin ® (treprostinil) Injection delivered intravenously to ...
Breaking Biology Technology:Global Compliance Service for Controlled Substances to Expand to China 2El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 2El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 3El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 4GenoSpace Expands Board with Appointment of Michelle Munson 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4
... /PRNewswire/ - Cytochroma today announced that it has appointed ... Company,s Scientific Advisory Board. , Dr. Cunningham is Professor ... Consultant Nephrologist at the Royal Free Hospital, London. His ... postgraduate training in The University of London and ...
... Oct. 15 /PRNewswire-Asia/ -- Sundia MediTech, a leading,pharmaceutical R&D ... D. Maher has been appointed Senior Vice President of ... Prior to joining Sundia, Mr. Maher was Executive Vice ... Group, a CRO company in,Florida, USA. Azopharma,s CRO ...
... Calif., Oct. 15 BlueFire Ethanol Fuels, Inc. (OTC ... world,s transportation fuel paradigm through the production of ethanol ... of its second planned biorefinery to Fulton, Mississippi. ... , After having been awarded a $40 million dollar ...
Cached Biology Technology:Cytochroma Appoints Dr. John Cunningham to its Scientific Advisory Board 2Cytochroma Appoints Dr. John Cunningham to its Scientific Advisory Board 3Sundia Appoints Charles D. Maher as Senior Vice President of Sales and Marketing 2Department of Energy Grants BlueFire Approval for Site Change 2Department of Energy Grants BlueFire Approval for Site Change 3Department of Energy Grants BlueFire Approval for Site Change 4
(Date:12/17/2014)... 2014 Valencell, a leader in performance biometric data ... industry leaders such as Intel, Jabra, Atlas, and Scosche ... products. These products will be showcased at CES 2015, ... . "Our partners choose PerformTek ...
(Date:12/15/2014)... Markets ( http://www.researchandmarkets.com/research/87pph8/global_facial ) has announced the ... report to their offering. ... technology used for the identification of individuals. Facial recognition ... such as nose, jaw edges, mouth, and the distance ...
(Date:12/11/2014)... , Dec. 10, 2014  That blood pressure plays a ... while. Hypertension – the medical term for high blood pressure ... 1800s, and the inflatable cuff that,s used in measuring blood ... mean there,s nothing new about hypertension, its triggers and its ...
Breaking Biology News(10 mins):Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3Research points to need for new approaches to treatment of high blood pressure 2Research points to need for new approaches to treatment of high blood pressure 3Research points to need for new approaches to treatment of high blood pressure 4
... Energy. This trio of problems is among ... Water purification alone is becoming more problematic in ... sources, such as polluted rivers, lakes and groundwater. , ... Rittmann, director of the Center for Environmental Biotechnology in ...
... Fruit lovers worldwide may soon enjoy new, healthier, tastier ... data which fruit breeders say will help revolutionise the ... fruit science company HortResearch, announced today that they would ... collection of apple DNA sequences. , The release comprises ...
... the Max Planck Institute for Dynamics and Self-Organization ... Göttingen together with the neurophysiologist Maxim Volgushev from ... the nerve cells in the cerebral cortex decide ... that the high flexibility and speed with which ...
Cached Biology News:Earth Rx: A microbial biotechnology prescription for global environmental health 2Earth Rx: A microbial biotechnology prescription for global environmental health 3HortResearch science reveals the natural potential of apples 2Why nerve cells work faster than the theory allows 2Why nerve cells work faster than the theory allows 3Why nerve cells work faster than the theory allows 4
... the first fully automated proteomics workcell. It ... with complete data tracking. It automates the ... through final protein expression and measurement. The ... a plate to any of its instruments ...
... columns is a well-known separation technique in ... are in DNA/RNA extraction in microbiology, viral ... in chemical or analytical laboratories. ,This ... series instruments for smaller scales. The extraction ...
... multi-functional program that searches for ... sequence file for polymerase chain ... mutagenesis, and various hybridization applications. ... secondary structure of oligonucleotides based ...
... structure visualization, phylogenetic tree building, sequence analysis, ... application. Retrieve sequences ... filter them in real-time Organize your ... filtering and sorting Provides up-to-date articles ...
Biology Products: