Biotech Values

[DewDiligence]

FDA Issues CRL for ABT/AZN’s Certriad

[Certriad is a pill that combines AZN’s Crestor and ABT’s TriLipix. As is typical in cases Big Pharma companies receive a CRL, this PR provides no details on what the FDA needs in order to approve.]

http://finance.yahoo.com/news/AstraZeneca-and-Abbott-prnews-2283953741.html?x=0&.v=1

›Tuesday March 30, 2010, 8:02 am

WILMINGTON, Del. and ABBOTT PARK, Ill., March 30 /PRNewswire-FirstCall/ -- AstraZeneca and Abbott (NYSE: ABT ) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules. The companies are currently evaluating the CRL, will continue discussions with the FDA to determine next steps with respect to the CERTRIAD NDA and will respond to the agency's request for additional information. [Can’t get any more laconic than that.]‹