Navigation Links
AstraZeneca Receives Complete Response Letter From US FDA For BRILINTA™ (Ticagrelor Tablets)

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA™).


In the CRL, the FDA requested additional analyses of the PLATO data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA.

AstraZeneca is evaluating the contents of the CRL and will respond to the agency's request for additional analyses of the PLATO data as soon as possible. The company remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency's questions.

"Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the BRILINTA NDA review," said Martin Mackay, President, Research & Development, AstraZeneca.


About BRILINTA™ (ticagrelor tablets)

BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA is the first reversibly-binding oral ADP receptor antagonist.

BRILINTA is currently under regulatory review in eighteen territories around the world and was granted marketing authorization under the trade name BRILIQUE™ by the European Commission (EC) on December 6, 2010.

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

About the PLATO study

PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel. The NDA submission for ticagrelor is based on the results of a comprehensive clinical trial program, including data from the PLATO study.

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 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. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
2. New Analysis of METEOR Study Demonstrate Effects of AstraZenecas CRESTOR(R) (Rosuvastatin Calcium) on Atherosclerosis in Patients With Two or More Risk Factors for Cardiovascular Disease
3. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
4. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
5. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
6. Volcano Announces Participation in SATURN Clinical Trial Sponsored by AstraZeneca
7. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
8. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
9. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
10. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
11. AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
Post Your Comments:
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... -- Guerbet announced today that it has been named a ... One of 12 suppliers to receive the ... of Premier members through exceptional local customer service and ... lower costs. "We ... customer service from Premier," says Massimo Carrara , ...
(Date:6/23/2016)... 23, 2016 The Biotechnology industry ... to present great opportunities to investors. assesses the ... Corp. (NYSE: XON ), Vertex Pharmaceuticals Inc. ... ARNA ), and Regeneron Pharmaceuticals Inc. (NASDAQ: ... and receive your complimentary trade alerts at: ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
Breaking Medicine News(10 mins):