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:3/26/2015)... Houston, Texas (PRWEB) March 26, 2015 ... nonprofit organization Health Fitness Revolution, founded by Samir Becic, ... based on their own personal health and fitness, as ... the political agenda. The list includes Sen. Ted Cruz, ... elections, as well as all other politicians who have ...
(Date:3/26/2015)... 26, 2015 CRN International took the ... to help celebrate the achievement of jobseekers from five ... serving some 500 people. , The program, called Platform ... in partnership with the Connecticut Department of Labor, ... unemployed workers and place them at appropriate companies. CRN, ...
(Date:3/26/2015)... Spring, Md. (PRWEB) March 26, 2015 ... participating in a pageant. Not until last year, when ... daughter Eliana has pulmonary hypertension (PH) – a debilitating ... the heart and can lead to right-heart failure. The ... was born in 2003. Lyndsi entered the pageant to ...
(Date:3/26/2015)... 2015 The beauty industry united on ... man who revolutionized the business of beauty education. The ... founder of Pivot Point International, Inc. Passage’s wife Lenie, ... Leo. Held at the Art Institute of Chicago, the ... industry and media leaders and served as the signature ...
(Date:3/26/2015)... NC (PRWEB) March 26, 2015 DiabetesSisters ... Inc. in the amount of $25,000 for a groundbreaking ... involves both DiabetesSisters and a partnering organization, The Society ... of a landmark report on women and diabetes. The ... of in need of research to improve the health ...
Breaking Medicine News(10 mins):Health News:How the Candidates for the 2016 Presidential Election Rank in Health and Fitness 2Health News:How the Candidates for the 2016 Presidential Election Rank in Health and Fitness 3Health News:CRN International Shows Support For Groundbreaking Connecticut Program To Aid The Unemployed 2Health News:Albuquerque Area Mom Enters Mrs. New Mexico Pageant to Help Fight Pulmonary Hypertension 2Health News:#BeautyChangesLives Legacy Award Pays Tribute to Industry Icon Leo Passage 2Health News:#BeautyChangesLives Legacy Award Pays Tribute to Industry Icon Leo Passage 3Health News:DiabetesSisters Receives Financial Support for Landmark Report from Janssen Pharmaceuticals 2
... HAWAII, OCTOBER 24, 2011) Heavy alcohol consumption may ... cancer, while higher BMI and increased consumption of black ... the deadly disease. In three separate studies presented at ... College of Chest Physicians (ACCP), heavy alcohol consumption was ...
... Holds Record for Highest Lung Cancer Mortality Rates , ... with other cities, Detroit has one of the highest ... lung cancer (NSCLC). Based on data from the National ... researchers from the McLaren Regional Medical Center in Flint, ...
... in cardiac surgery who receive extra training on a take-home ... operating room, Dr. Buu-Khanh Lam today told the Canadian Cardiovascular ... the Canadian Cardiovascular Society. Dr. Lam and a ... and miniature tubing that can be taken home by ...
... with tissue from their own abdomen experience significant gains ... three weeks after surgery. That is one of the ... Cancer , a peer-reviewed journal of the American ... breast cancer survivors who are contemplating these types of ...
... 22 (HealthDay News) -- While there are challenges, Halloween can ... "They can enjoy Halloween and enjoy some of the ... a pediatric endocrinologist and senior scientist at the University of ... news release. "We give parents and kids three options ...
... used nonsteroidal anti-inflammatory drugs for at least 10 years ... Initiative study had a lower risk for death from ... of these drugs at enrollment, according to data presented ... Cancer Prevention Research, held Oct. 22-25, 2011. "Our ...
Cached Medicine News:Health News:Heavy alcohol consumption linked to lung cancer 2Health News:CHEST 2011: Embargoed studies highlight new lung cancer and COPD research 2Health News:CHEST 2011: Embargoed studies highlight new lung cancer and COPD research 3Health News:Heart surgeons-in-training benefit from hands-on homework 2Health News:Advanced post-mastectomy breast reconstruction improves women's psychosocial and sexual well-being 2Health News:Healthy Halloween Advice for Children With Diabetes 2Health News:NSAID use associated with lower colorectal cancer mortality rates among postmenopausal women 2
(Date:3/26/2015)... Ohio entrepreneur is introducing a product designed to give people ... start-up company known as SEED Protocol LLC, ... empower individuals to manage, review, and protect their healthcare files, ... The SEED Protocol – ... to protect their own health records by storing them in ...
(Date:3/26/2015)... 2015 IGI Laboratories, Inc. (NYSE MKT: IG), ... generic pharmaceutical company, today announced it has submitted its ... Food and Drug Administration (FDA) of 2015, which brings ... at the FDA to twenty-three. Jason ... "On March 2, 2015, we committed to file at ...
(Date:3/26/2015)... Gelesis , a clinical stage ... products to induce weight loss and improve glycemic ... financing of shares of convertible preferred stock for ... conversion of approximately $4 million of outstanding convertible ... used to support the continued clinical development of ...
Breaking Medicine Technology:Ohio Entrepreneur Develops Technology that Allows Patients Control Over Their Healthcare Records 2Ohio Entrepreneur Develops Technology that Allows Patients Control Over Their Healthcare Records 3Ohio Entrepreneur Develops Technology that Allows Patients Control Over Their Healthcare Records 4IGI Laboratories, Inc. Announces First ANDA Submission Of 2015 2Gelesis Closes $22M Equity Financing 2Gelesis Closes $22M Equity Financing 3
... Regional Medical Center is expanding its emergency care ... AirLife Denver medical helicopter service in Cheyenne. The ... HCA-HealthONE, which operates AIRLIFE Denver. (Photo:   ... sonic green helicopter will be stationed in Cheyenne and ...
... Ill., Nov. 11, 2011 Patients who are dependent on ... knee replacement surgery have much more difficulty recovering, ... and Joint Surgery (JBJS) has found. These ... a higher rate of complications, and are more likely to ...
Cached Medicine Technology:Cheyenne Regional Medical Center Announces New Air Ambulance Service Partnership with HealthONE's AirLife Denver 2Cheyenne Regional Medical Center Announces New Air Ambulance Service Partnership with HealthONE's AirLife Denver 3Take Care with Pain Meds 2Take Care with Pain Meds 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: