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Advisory Committee Briefing Materials For Brilinta (Ticagrelor) NDA Available On US FDA Web Site

Posted: 26 July 2010 | | No comments yet

The FDA posted briefing materials in advance of 28th July 2010 CRDAC to discuss the New Drug Application (NDA) filed by AstraZeneca…

The FDA posted briefing materials in advance of 28th July 2010 CRDAC to discuss the New Drug Application (NDA) filed by AstraZeneca...

The US Food and Drug Administration (FDA) today posted briefing materials in advance of 28th July 2010 Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to discuss the New Drug Application (NDA) filed by  for its investigational oral antiplatelet ticagrelor. The proposed trade name for ticagrelor in the US is BRILINTA, pending approval from the FDA.

The briefing materials can be found on the FDA web site.

On 19th November 2009, AstraZeneca announced it had submitted an NDA to the FDA for ticagrelor, for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).