Navigation Links
Indevus Receives Non-Approvable Letter From FDA for VALSTAR(TM)
Date:12/19/2007

rket as quickly as possible."

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 acquired VALSTAR through its acquisition of Valera Pharmaceuticals and after completing the resolution of the impurity issue, submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007.

About VALSTAR(TM)

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 trials, when provided after transurethral resection, VALSTAR patients had a median 21 months to documented recurrence of disease.

VALSTAR has been shown to induce complete response in only about 1 in 5 patients with BCG-refractory CIS. It is important to note that delaying cystectomy could lead to development of metastatic bladder cancer.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA(R) XR and SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of inf
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
2. Indevus Announces Allergan as New Partner for SANCTURA Brand
3. Indevus Pharmaceuticals Announces Retirement of David B. Sharrock From Its Board of Directors
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
6. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
7. IsoTis Receives FDA Clearance for Accell Family of Products
8. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
9. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
10. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
11. XTL Receives Staff Letter From NASDAQ
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... January 15, 2014 DTS Language Services, ... Online Web Portal for Life Science organizations who need document ... the subject matter of their documents in advance with a ... reduce time-to-delivery of translations, often a critical factor in clinical ...
(Date:1/15/2014)... 2014 AudioNotch is the internet's leading ... the treatment of tinnitus. Patients listen to sound therapy ... a period of weeks to months, their tinnitus volume decreases. ... forms: Notched Music and Notched White Noise. Now, AudioNotch is ...
(Date:1/14/2014)... Carahsoft and CDS Federal Services have ... at 2pm EST (11am PST), “Natural Language Processing: Converting ... how technology can turn raw, heterogeneous data into actionable ... The online webinar will last approximately one hour. , ...
(Date:1/14/2014)... , Jan. 14, 2014 As pet owners drew up ... many of them wrote: "Take better care of my furry companion." ... designer clothes and top-brand carrying cases to take the little canine ... might also feel compelled to buy some pricey toys at the ...
Breaking Biology Technology:DTS Improves Efficiency for Life Science Document Translations 2Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2
... Trius Therapeutics, Inc. today announced that it has been ... the Defense Threat Reduction Agency (DTRA), an agency within the ... directed against gram-negative bacterial pathogens. Trius may receive up to ... the new DTRA contract, which is funded as part of ...
... the United States, over the past four decades, have ... them involving bombs or explosives, says a new report ... Study of Terrorism and Responses to Terrorism (START). ... from the Center,s Global Terrorism Database (GTD), the world,s ...
... , May 18 Patient and professional ... marketplace on new medicines. Effectively collaborating with advocacy groups ... and is especially critical for socially sensitive conditions/therapies. " ... " is a 125-page report from Best Practices, LLC ...
Cached Biology Technology:Trius Therapeutics Awarded U.S. Department of Defense Contract to Develop Novel Antibiotics 2Trius Therapeutics Awarded U.S. Department of Defense Contract to Develop Novel Antibiotics 3US terror concentrated in New York City; bombs weapon of choice 2Educating the Marketplace Through Collaborations with Patient Advocacy Groups 2Educating the Marketplace Through Collaborations with Patient Advocacy Groups 3
(Date:4/18/2014)... [Brown University] Asteroid and comet impacts can cause ... regional or even global scales. But new research from ... signatures of ancient life at the time of an ... Pete Schultz has found fragments of leaves and preserved ... ancient impacts in Argentina. The material could provide a ...
(Date:4/17/2014)... was a word for chili peppers. Information about archaeological ... a study of the appearance of words for chili ... jalapeos were domesticated and highlight the value of multi-proxy ... et al.) of nine papers presented in a special ... Academy of Sciences on plant and animal domestication ...
(Date:4/17/2014)... ALBUQUERQUE, N.M. A credit-card-sized anthrax detection cartridge developed ... small business makes testing safer, easier, faster and cheaper. ... causes anthrax, is commonly found in soils all over ... illness in both humans and animals. The bacteria can ... to B. anthracis may occur through skin ...
Breaking Biology News(10 mins):Impact glass stores biodata for millions of years 2Impact glass stores biodata for millions of years 3Chickens to chili peppers 2Chickens to chili peppers 3Pocket-sized anthrax detector aids global agriculture 2Pocket-sized anthrax detector aids global agriculture 3
... the mechanism that binds skin cells tightly together, which ... and debilitating skin diseases and also lethal heart defects. ... Sciences, has found that the glue molecules bind only ... very tough, resilient structure. Further investigation on why the ...
... NASA,s newest Earth-observing research mission is nearing launch. The ... sun and tiny atmospheric particles called aerosols affect Earth,s ... solar measurements needed to address key uncertainties about climate ... Vandenberg Air Force Base in California on Feb. 23 ...
... little more than a conventional photocopier and transparency film, ... local Cambridge high school physics teacher invented the process; ... Harvard,s School of Engineering and Applied Sciences (SEAS), students ... The Microfluidics Lab, developed by Dr. Anas Chalah, Director ...
Cached Biology News:Cell binding discovery brings hope to those with skin and heart problems 2NASA prepares to launch next Earth-observing satellite mission 2NASA prepares to launch next Earth-observing satellite mission 3Simple, ingenious way to create lab-on-a-chip devices could become a model for teaching and research 2Simple, ingenious way to create lab-on-a-chip devices could become a model for teaching and research 3
Mouse monoclonal [MLM544] to cardiac Myosin light chain 1 ( Abpromise for all tested applications). entrezGeneID: 4634 SwissProtID: P08590...
Request Info...
Mouse monoclonal [J53] to Thyroid Hormone Receptor beta 1 ( Abpromise for all tested applications). entrezGeneID: 7068 SwissProtID: P10828...
Polyclonal Antibody to TRIB1/ SKIP1/ Tribbles 1...
Biology Products: