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Novo Nordisk A/S disclosed in its 1H13 earnings on Thursday that it received in June a second complete response letter from FDA for a BLA for recombinant factor XIII (rFXIII) to treat congenital Factor XIII deficiency, a rare bleeding disorder. According to Novo, FDA said completion of the review of the BLA is “pending the resolution of findings at an inspection of the manufacturing facility.” The company said it is working with FDA to address the issues. Novo disclosed that it received the first complete response letter for the product in February 2012.
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