Navigation Links
AstraZeneca Receives Six Months Pediatric Exclusivity Patent Extension for ARIMIDEX(R) (anastrozole) from the FDA
Date:11/29/2007

WILMINGTON, Del., Nov. 29 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the United States (US) Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market ARIMIDEX(R) (anastrozole) for its licensed breast cancer indications until June 2010. Prior to pediatric exclusivity being granted by the FDA, the patent was due to expire in December 2009.

ARIMIDEX is currently approved in the US for the for the following indications:

-- The adjuvant treatment (treatment following surgery with or without

radiation) of postmenopausal women with hormone receptor positive early

breast cancer (Sub Part H approval granted in 2002, final approval in

2005).

-- The first-line treatment of postmenopausal women with hormone receptor

positive or hormone receptor unknown locally advanced or metastatic

breast cancer (granted in 2000).

-- The treatment of advanced breast cancer in postmenopausal women with

disease progression following tamoxifen therapy. Patients with hormone

receptor-negative disease and patients who did not previously respond

to tamoxifen therapy rarely responded to ARIMIDEX (granted in 1995).

Dr. John Patterson, Executive Director of Development at AstraZeneca said "Pre-clinical and clinical data supported the investigation of the therapeutic potential of ARIMIDEX in pediatric conditions that manifest symptoms resulting from increased estrogen production, for example: gynecomastia in pubertal boys and precocious puberty in girls with McCune-Albright Syndrome (MAS). While pleased to have been able to work with the FDA in investigating the potential benefits of ARIMIDEX in these settings, AstraZeneca will not be seeking an indication in either of these pediatric conditions based on trial results."

In the US, ARIMIDEX sales reached $507 million for the nine months of 2007. ARIMIDEX has a
'/>"/>

SOURCE AstraZeneca
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. AstraZeneca Leads Local Walking Movement
2. AstraZeneca Joins Local Walking Movement
3. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
4. Verus Pharmaceuticals Announces Divestiture of Pediatric Asthma Development Programs to AstraZeneca
5. AstraZeneca Recognized as One of Working Mothers 100 Best Companies for the Sixth Consecutive Year
6. AstraZeneca Launches New Program to Support Facilities that Connect People to Needed Medical Care and Prescription Assistance
7. NPS Sells Assets Related to mGluR Collaboration to AstraZeneca for $30 Million to Support Late-Stage Product Development
8. Everett-Area Cancer Patients Can More Easily Navigate Health Care System Thanks to the American Cancer Society and AstraZeneca
9. Perrigo Announces that Dexcels Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
10. AstraZeneca Response to November 2, 2007 Ruling In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts
11. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2014)... 17, 2014) Doctors who treat patients with ... (LAM) can face an agonizing treatment decision. , ... disease and help relieve shortness of breath. But ... sirolimus can cause potentially fatal complications following transplantation. ... Daniel Dilling, medical director of Loyola University Medical ...
(Date:4/17/2014)... University School of Medicine (BUSM) have discovered that ... an experimental model. The findings, reported in the ... , may lead to more effective treatments for ... of the leading causes of illness and death ... impact by limiting the productivity of workers and ...
(Date:4/17/2014)... April 2014) Population Council scientists and their partners have ... and can prevent the transmission of multiple sexually transmitted ... animals: HIV, herpes simplex virus 2 (HSV-2), and human ... data that the gel is effective against multiple strains ... the vagina against all three viruses of at least ...
(Date:4/17/2014)... A new study has found that India,s shocking rates ... debt-ridden farmers who are clinging to tiny smallholdings ... ,cash crops, such as cotton and coffee, that are ... supports a range of previous case studies that point ... sector following the ,liberalisation, of the nation,s economy during ...
(Date:4/17/2014)... have called for more research to be carried ... in sub-Saharan Africa. In a paper in ... Stothard, working with colleagues in the department of ... in Cleveland Ohio, University of Cambridge and the ... the joint burden of HIV/AIDS and schistosomiasis of ...
Breaking Medicine News(10 mins):Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 2Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 3Health News:More research called for into HIV and schistosomiasis coinfection in African children 2
... University School,s of Medicine (BUSM), Management (SMG) and Law ... Health, believe that public-sector research has had a more ... realized. The findings, which appear as a Special Article ... England Journal of Medicine , have economic and policy ...
... HealthDay Reporter , WEDNESDAY, Feb. 9 (HealthDay News) ... genome revealed never-before-seen changes in DNA that may contribute ... the full genetic blueprint of the tumor, researchers hope ... more targeted drugs and a better understanding of which ...
... The payoff for investing in public parks and recreation ... a less strained healthcare system, according to Penn State ... dramatic effect on health and fitness, say Geof Godbey, ... professor of recreation and parks management. "There is a ...
... may help diagnose heart disease, cancers, HIV and other ... clinical methods. The microsponges are an essential component of ... a new paper in the journal Small . ... Professor in Bioengineering and Chemistry, and his colleagues at ...
... demonstrates that vulvar cancer occurs most frequently in women age 65 ... cancer are age 70 or older, and the rate increases with ... years of age. , A team of researchers headed by Ashley ... Oncology at Women & Infants Hospital of Rhode Island, recently presented ...
... , WEDNESDAY, Feb. 9 (HealthDay News) -- Poor memory and ... increased risk for stroke, a new study suggests. Researchers gave ... were give a verbal fluency test designed to measure the brain,s ... (average age 67) and had never had a stroke, were then ...
Cached Medicine News:Health News:Researchers find public sector research responsible for many new drug discoveries 2Health News:Researchers find public sector research responsible for many new drug discoveries 3Health News:First Look at Prostate Cancer Genome Yields Insights 2Health News:First Look at Prostate Cancer Genome Yields Insights 3Health News:Key to better health care may be a walk in the park 2Health News:Microsponges from seaweed may save lives 2Health News:Microsponges from seaweed may save lives 3Health News:Researchers: Elderly patients 4 times more likely to die from treatment complications 2Health News:Could Poor Memory Signal Raised Stroke Risk? 2
(Date:1/15/2014)... Ky. , Jan. 15, 2014  Manufacturers, suppliers ... must be able to protect their most important ... http://photos.prnewswire.com/prnh/20130716/CL46586LOGO ) Because of ... it steadfastly remains one of the most litigious ...
(Date:1/15/2014)... , Jan. 15, 2014 The Cadence Fitness ... Fitness Center by the Medical Fitness Association, a non-profit ... achieve their full potential. The Cadence Fitness & Health ... western suburbs and second in the Chicagoland area. ...
(Date:1/15/2014)... 15, 2014 Reportlinker.com announces that a ... its catalogue: Global ... Systems -- Focus on End Users ... OBJECTIVES A drug delivery system ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 16Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 17Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 18
Lyphochek Therapeutic Drug Monitoring Control (TDM) contains over 40 analytes with assayed values at three clinically significant levels....
Lyphochek Urine Metals Control incorporates two levels of critical trace elements, heavy metals and organic metabolites, and is ideal for environmental and industrial testing....
Liquichek Whole Blood Volatiles Control is an assayed liquid control for monitoring volatile compounds. This product is available in 2 levels....
Lyphochek Urine Bone Markers Control is a bilevel human urine based control designed to monitor tests for urinary markers of osteoporosis management and bone resorption....
Medicine Products: