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名前：Alexandra日付：2014/12/27 08:01:00
Could I have a statement, please? precose
The NDA for XARTEMIS XR was accepted by the FDA on July 29, 2013, and was granted priority review, which meant a decision by Jan.29, 2013. Now the three-month extension of the decision date from the FDA is in response to additional data submitted by Mallinckrodt.
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