The FDA delays by three months (until Jan. 28) a decision on whether to approve AstraZeneca's...


The FDA delays by three months (until Jan. 28) a decision on whether to approve AstraZeneca's (AZN) and Bristol-Myers Squibb's (BMY) dapagliflozin diabetes pill. In July, an FDA advisory panel voted against approving the medicine, saying more safety information was needed. (PR)

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  • Spencer Knight
    , contributor
    Comments (389) | Send Message
     
    "The Food and Drug Administration postponed its decision on the drug, dapagliflozin, while asking the companies to submit data from recent completed and ongoing late-stage clinical trials..."

     

    Looks like the FDA may want to approve dapagliflozin and is going to give BMY and AZN another chance to prove the drug is not a direct cause of bladder cancer and bladder infections without sending a CRL. Who knows, sometimes delays lead to a rejection anyways.
    27 Oct 2011, 03:29 AM Reply Like
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