ARTICLE
12 November 2015

FDA Withdraws New Drug Applications And Abbreviated New Drug Applications

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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.
United States Food, Drugs, Healthcare, Life Sciences

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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