US FDA approves BRILINTA (ticagrelor) tablets


A worker inspects BRILINTA bottles at AstraZeneca’s US supply and manufacturing division located in Newark, Delaware. The Newark facility serves as a major distribution and shipping center for AstraZeneca.

AstraZeneca announced yesterday that the US Food and Drug Administration (FDA) approved BRILINTA™ (ticagrelor) tablets. The approval of BRILINTA is a demonstration of the company’s mission to deliver medicines to help meet patient needs.

The US approval comes just six months after approval of ticagrelor in the European Union in December 2010. It is now approved across five continents, specifically 39 countries, including US, Brazil, Australia, and Canada under the trade name BRILINTA and in the European Union under the trade name BRLIQUE™. BRILINTA is currently under regulatory review in an additional 45 countries, including Russia, India, and China.

Ticagrelor was discovered and developed by AstraZeneca’s own scientists in our laboratories in the United Kingdom. It will be manufactured in Sweden and bottled and packaged in Newark, Delaware for distribution to US patients.

For additional information about BRILINTA, click here. Please read full Prescribing Information, including BOXED WARNINGS and Medication Guide at http://www1.astrazeneca-us.com/pi/brilinta.pdf.

-By Rachelle Benson, Senior Manager for Brand Corporate Affairs at AstraZeneca