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:8/4/2017)... Md. , Aug. 4, 2017 The ... or shortly after a physician/patient consult has long been ... and was a notable focus of the largest meeting ... is according to healthcare market research firm Kalorama Information. ... care testing (POCT) offerings or related supplies and software ...
(Date:8/2/2017)... -- Life Flight Network and PeaceHealth Oregon Network announced they renewed ... operational efficiency for patients at hospitals in Eugene ... Grove , and Florence, Oregon , ... Network work collaboratively to move patients who require the highest ... sensitive emergency exists. ...
(Date:7/31/2017)... 7D Surgical, developer of ground breaking surgical navigation ... Surgical System to support its strategic sales plan in ... and Virginia.  7D Surgical has entered into an exclusive sales ... medical facilities within those markets. ... Spartan Medical Purchases ...
Breaking Medicine Technology:
(Date:8/22/2017)... , ... August 22, 2017 , ... “Wilderness Voices”: a ... world travel. “Wilderness Voices” is the creation of published author, Martha McKown, an ... McKown was inspired as a very young child when her older sisters studied High ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Glimpses Of Light”: is a unique ... Of Light” is the creation of published author, J.M. Shepherd, a writer, teacher, traveler, ... to life’s perplexing mysteries. , Shepherd shares, “Love is one of the least understood ...
(Date:8/22/2017)... ... 22, 2017 , ... “Call Of Spiritual Duty”: a revelation in an era ... C.S. Lizarde. Growing up on the streets of North Visalia, California, Carlos Lizarde ... apply the Biblical keys to his life, he noticed immediately that opportunities and blessings ...
(Date:8/21/2017)... Ca (PRWEB) , ... August 22, 2017 , ... ... industries, but not without risk to health and safety. By learning and implementing ... be eliminated. , In this webinar, attendees will gain a better understanding ...
(Date:8/21/2017)... Aliso Viejo, CA (PRWEB) , ... August 21, 2017 , ... ... Pixel Film Studios. Editors can quickly and easily add washed color grades to ... an image. The LUT changes every pixel’s color to the corresponding color indicated by ...
Breaking Medicine News(10 mins):