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December 23, 2010

AstraZeneca and Abbott Pull NDA for Lipidemia Drug

  • AstraZeneca and Abbott are ceasing development of the FDA-filed mixed lipidemia therapy candidate Certriad™. The drug is a combination of AstraZeneca’s Crestor (rosuvastatin calcium) and Abbott’s Trilipix (fenofibric acid).

    The firms had filed an NDA with FDA for Certriad in June 2009. In March received a complete response letter (CRL) from the agency.

    They say the joint decision to drop the drug follows a careful review of the CRL and the resulting regulatory delay, which led them to conclude that development of Certriad is no longer commercially viable.

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