Navigation Links
U.S. Food and Drug Administration Extends Review Timeline for BRILINTA (Ticagrelor) New Drug Application

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).



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.



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: 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:
(Date:11/26/2015)... WILMINGTON, North Carolina , 26 november ... Laboratories, Inc. (AAIPharma/CML) kondigt de geplande investering ... de uitbreiding van de laboratoria en het ... . De uitbreiding zal resulteren in ... waarmee wordt voldaan aan de groeiende behoeften ...
(Date:11/26/2015)... -- Research and Markets ( ) has announced the ... to 2019 - Rise in Cardiac Disorders and Growing Awareness ... their offering. Boston scientific ... scientific and others. --> The market is ... Boston scientific and others. ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
Breaking Medicine Technology:
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... American Express Travel Representative. As a franchise owner, Somu now offers travelers, value ... cruise, destination wedding packages, private cruise sales, as well as, cabin upgrades and ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... PRMA Plastic ... November 19, 2015, our surgeons performed their 6,000th free flap breast reconstruction surgery! , ... wake up every day excited to rebuild lives and it’s an honor to have ...
(Date:11/26/2015)... Karnataka (PRWEB) , ... November ... ... innovative online platform for mental health and wellness consultation, has collaborated with ... to holistically address their reader’s queries on topics on mental and emotional ...
(Date:11/25/2015)... ... November 25, 2015 , ... As ... Water For Empowerment ™ attracts volunteers together who want to combine talents and ... as key stakeholders in the process. The non-profit launched its first major fundraiser ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... been recognized once again for its stellar workplace culture with the company’s Cincinnati ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business ...
Breaking Medicine News(10 mins):