Navigation Links
AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA
Date:9/22/2008

WILMINGTON, Del., Sept. 22 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009. AstraZeneca has been working with the FDA in the investigation of the safety and effectiveness of CASODEX in a pediatric setting but will not be seeking an indication in this population.

CASODEX is currently approved in the US at a dose of 50 mg daily tablet for use in combination with a luteinizing hormone-releasing hormone analog (LHRH-A) for the treatment of advanced prostate cancer (metastatic Stage D2).

AstraZeneca has a well-established prostate cancer portfolio including hormonal treatments CASODEX, launched in 1995, and ZOLADEX(R) (goserelin acetate implant), launched in 1989. Three Phase III clinical research trials (ENTHUSE program) are currently underway to evaluate the safety and effectiveness of an investigational compound, ZD4054, in non-metastatic and metastatic hormone-resistant prostate cancer.

About Prostate Cancer

Over 186,000 men will be diagnosed with prostate cancer in the U.S. in 2008, making it the most frequently diagnosed cancer in men.(1) After lung cancer, prostate cancer is the second leading cause of cancer death in men, with an estimated 28,660 deaths in 2008.(2) One in six men will develop prostate cancer in his lifetime.

About CASODEX(R) (bicalutamide) Tablets

CASODEX at a dose of 50 mg daily is a prescription medication approved for use in combination with an injection of a luteinizing hormone-releasing hormone analog (LHRH-A) for treatment of advanced prostate cancer (metastatic Stage D2).

CASODEX at a dose of 150 mg daily is not approved for use alone or with other treatments. See full Prescribing Information under the section on "CLINICAL PHARMACOLOGY-Clinical Studies-Safet
'/>"/>

SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimers Disease
2. AstraZeneca Announces Innovative New Partnership With Singapore Institutions to Develop Anti-Cancer Compounds
3. AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
4. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
5. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
6. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
7. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
8. Volcano Announces Participation in SATURN Clinical Trial Sponsored by AstraZeneca
9. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
10. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
11. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/2/2015)... , June 26, 2015 Research ... "Vitamin D Market by Analog, Application, End-User & by ... to their offering. This market is projected to ... vitamin D in different applications and rising opportunities in countries ... , Italy , and ...
(Date:7/2/2015)... July 2, 2015   EVO Aesthetic Center and ... provider for non-invasive aesthetics in Lakeway, Texas ... treatments with the Astanza Duality laser. The medical spa ... through various medical and laser procedures. Their addition of ... a clear solution to their tattoo regret. ...
(Date:7/2/2015)... 2015 Numotion,s Board of Directors and ... Tamas Feitel has joined the Company as Chief ... highly successful 18 year career at GE serving in ... and productivity to result in significant industry leading growth ... Financial Officer for GE Healthcare Global Services, a $5B ...
Breaking Medicine Technology:Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 2Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 3EVO Offers Advanced Laser Tattoo Removal With Astanza Duality In Lakeway, TX 2Numotion Names Tamas Feitel Chief Financial Officer 2
... Timothy Mastro,MD, FACP, DTM&H, who joins Family Health ... Research, will share information on promising,research into pre-exposure ... Conference in Mexico City., Dr. Mastro,s presentation, ... ongoing and upcoming clinical trials that,suggest oral doses ...
... Key Thought,Leaders Explore Critical Next Steps for AIDS Vaccine ... NEW YORK, July 28 The following was ... Today, AIDS vaccine research is at a pivotal ... to reach late-stage testing failed.,In the wake of this ...
Cached Medicine Technology:HIV Prevention Expert Dr. Timothy Mastro Speaks on Future of Pre-Exposure Prophylaxis at International AIDS Conference 2AIDS Vaccines: Where Do We Go From Here? 2
(Date:7/2/2015)... (PRWEB) , ... July 02, 2015 , ... With summer in full swing, Americans are ... is one of the top spots for fishing in the world, and it’s easy to ... of Ontario, Canada has great fish. , Recreational fishing is a huge industry, and ...
(Date:7/2/2015)... ... July 02, 2015 , ... “ LIFX ” was featured ... coolest technology products available to consumers. Amanda Forstrom, a technology expert and special reporter ... the most versatile smart light bulbs on the market. , According to the U.S. ...
(Date:7/2/2015)... ... July 02, 2015 , ... ... of the SIGVARIS PERFORMANCE SOCKS. Since the socks were first introduced, they have ... Their significant popularity has inspired four new, fun shades including: blue, lime, pink ...
(Date:7/2/2015)... , ... July 02, 2015 , ... Six months ahead ... solo cross-country walk to raise awareness and money for the Pulmonary Hypertension Association ... arrive at PHA’s headquarters near Washington, D.C. by mid-September. He left Glasgow, Mont. yesterday ...
(Date:7/2/2015)... ... July 02, 2015 , ... ActiveBunch.com recently launched as a social network ... to function as a lifestyle community, Active Bunch allows users to connect with like-minded ... and participate in discussions or group events. , The spokesperson for Active Bunch ...
Breaking Medicine News(10 mins):Health News:The Most Versatile Smart Light Bulbs were featured on NewsWatch Television 2Health News:SIGVARIS is Sporting Four Brand New Colors in the Popular PERFORMANCE SOCK Product Line 2Health News:79-Year-old ‘Pacing Parson’ Passes 1,000-Mile Mark in Cross-Country Walk for Pulmonary Hypertension Association 2Health News:79-Year-old ‘Pacing Parson’ Passes 1,000-Mile Mark in Cross-Country Walk for Pulmonary Hypertension Association 3Health News:ActiveBunch.com Launches as a Social Community for People with Active Lifestyles 2
... ... accepted CoolTouch,s request to re-examine the ,873 Paolini laser lipolysis patent based on prior art ... ... the United States Patent & Trademark Office (USPTO) accepted CoolTouch,s request to re-examine the ,873 ...
... ... Hepatitis C and their physicians, caregivers and families, has been redesigned. New features include ... ... The go-to website that provides a wealth of information and news updates about ...
... 2 The University HealthSystem Consortium (UHC) today announced ... added to Spend LINK (TM), UHC,s proprietary supply chain ... optimize their pricing and achieve maximum savings. , ... hospital,s expenditure, making it the second largest expense after ...
... at Westmead are embarking on a ground-breaking new study ... resistance in overweight adolescents can put the brakes on ... diabetes affects 85 to 90 per cent of all ... younger people and children are increasingly being diagnosed. Often ...
... for ,Loose Chains, joins researchers, physicians, neurosurgeons and other brain tumor ... Medical Center , , LOS ... have to work around scheduling conflicts, but Eddie Cleland, drummer for ... to accommodate brain tumor surgery, which was performed by ...
... well known to stop or suppress cancer plays a role in ... of Michigan Comprehensive Cancer Center. The researchers found that several pathways ... breast cancer stem cells. Further, by using a drug that ... percent decrease in the number of cancer stem cells within a ...
Cached Medicine News:Health News:United States Patent and Trademark Office Accepts CoolTouch's Re-examination Request for Cynosure '873 Patent 2Health News:Resource for Those Living with Hepatitis C Announces Website Redesign 2Health News:University HealthSystem Consortium Adds Price Competitive Index to Its Spend Analytics Tool 2Health News:Ground-breaking study to cap the growing trend of type 2 diabetes in overweight adolescents 2Health News:Drummer Eddie Cleland Resumes Life After Brain Surgery and Tells About it at Conference 2Health News:Drummer Eddie Cleland Resumes Life After Brain Surgery and Tells About it at Conference 3Health News:Drummer Eddie Cleland Resumes Life After Brain Surgery and Tells About it at Conference 4Health News:U-M researchers link pathway to breast cancer stem cells 2
West 2 periosteal elevators....
Alexander periosteal elevators....
Sedillot periosteal elevators....
Modified Freer periosteal elevator, #163, slight curve, 21 cm....
Medicine Products: