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:4/27/2016)... 2016  Hologic, Inc. (Nasdaq: HOLX ... the fiscal second quarter ended March 26, 2016.  ... increased 41.2%, and non-GAAP diluted EPS of $0.47 ... on a reported basis, and 6.3% on a ... another good quarter, highlighted by 14.6% growth in ...
(Date:4/27/2016)... -- Elekta today announced that its leading-edge ... focal point of seven scientific presentations at ESTRO 35, ... & Oncology, taking place April 29 - May 3. ... and a high-field MRI scanner with sophisticated software that ... in real time. The MR-linac is designed to improve ...
(Date:4/27/2016)... SHAWNEE, Kan. , April 27, 2016 /PRNewswire/ ... Martabano , a senior from the University of ... winner of the Bayer Excellence in Communication Award ... veterinary schools, which were awarded a total of ... Over the last four years, Bayer has provided ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... ... won the $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan ... the Michelson People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... patented products, announces the Gyrociser, an exercise invention which aids in proper muscle ... says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Globalization has ...
(Date:4/29/2016)... , ... April 29, 2016 , ... Melanoma is the deadliest type of skin cancer. ... for the majority of skin cancer deaths. More than 10,000 people are expected to die ... diagnosis is 62, it is the one of the most commonly diagnosed cancers in young ...
(Date:4/29/2016)... ... ... City based oral and maxillofacial surgeon Dr. Majid Jamali is an expert in ... apnea. Dr. Jamali is proud to offer this permanent solution to patients who suffer from ... bones. This surgery is performed to correct the alignment of the jaw. It is beneficial ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... For those ... as the meal to miss. That was among the many new lifestyle diet tips ... a recent Sharon Kleyne Hour® Power of Water® radio show. Bonny and Lawrence noted ...
Breaking Medicine News(10 mins):