Monday, January 24, 2011

AstraZeneca Responds to FDA Letter

Zacks.com submits:

AstraZeneca (AZN) recently submitted a response to the Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) for Brilinta (ticagrelor). In its response, the company has provided additional analyses of the Study of Platelet Inhibition and Patient Outcomes (PLATO) as requested by the FDA. AstraZeneca is looking to get Brilinta approved for the treatment of acute coronary syndrome (ACS).

CRL Issued in Dec 2010


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