United States:
FDA Withdraws New Drug Applications And Abbreviated New Drug Applications
12 November 2015
Jones Day
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In the October 13, 2015, Federal Register, FDA
announced that it is withdrawing approval of 67 new drug
applications ("NDAs") and 128 abbreviated new drug
applications ("ANDAs") from multiple applicants. The
holders of the applications notified the Agency in writing that the
drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
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