Navigation Links
U.S. Food and Drug Administration Extends Review Timeline for BRILINTA (Ticagrelor) New Drug Application
Date:9/15/2010

WILMINGTON, Del., Sept. 15 /PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (BRILINTA).

(Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO)

Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from September 16, 2010 to December 16, 2010. AstraZeneca will continue to work closely with the FDA to support the review of the ticagrelor NDA.

Ticagrelor is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil.

NOTES TO EDITORS:

ABOUT BRILINTA/BRILIQUE

Ticagrelor (BRILINTA/BRILIQUE) is an investigational oral antiplatelet treatment for Acute Coronary Syndromes (ACS). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion dollar healthcare business.

For more information about AstraZeneca in the US or the AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).


'/>"/>
SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. K-V Pharmaceutical Company Announces Completion of U.S. Food and Drug Administration Inspection and Approval to Return its First Product to Market
2. Americans to U.S. Food and Drug Administration: Preserve Life-Saving Medicines; Reduce Antibiotic Use in Food Animal Production
3. Veterans Administration Health Care System Purchases 15 Zargis Cardioscan Systems
4. American Heart Association Comment: Advisory Committee Recommends that U.S. Food and Drug Administration Keep Rosiglitazone (Avandia) on the Market, Continue Clinical Trial of Safety and Efficacy
5. Sperian Respiratory Protection USA Awarded a 65,000 Reusable Respirator Order by the Veterans Health Administration
6. Soligenix Announces Publication of Positive Data Describing Protection from Mucosal and Systemic Ricin Intoxication by Intradermal RiVax™ Administration
7. Kun Run Biotechnology Announces That They Have Obtained the Manufacturing Approval for Entecavir from the China State Food and Drug Administration
8. Hospira to Standardize Intravenous (I.V.) Administration Sets Portfolio to Non-DEHP
9. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
10. Federal Aviation Administration Selects Partners For Nationwide AED Program
11. Chinese State Food and Drug Administration Approves Company Facility for Producing Solid Dosage Perindopril
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today ... Las Piedras, Puerto Rico , where ... Following a comprehensive ... minor structural damage, temporary loss of power and minimal ... completed, manufacturing operations have resumed, and the company expects ...
(Date:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a ... of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners ... October 11, 2017. , The annual award competition recognizes editorial and design excellence across ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... one of Michigan’s 2017 Best and Brightest in Wellness® by Best and Brightest. ... awards program on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. at ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vohra Chief Medical ... to physician colleagues, skilled nursing facility medical directors and other clinicians at various ... Wound Care." , "At many of these conferences we get to educate other ...
Breaking Medicine News(10 mins):