The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications notified ...
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83 FR 28856
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“Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications,” thefederalregister.org (June 21, 2018), https://thefederalregister.org/documents/2018-13293/novartis-pharmaceuticals-corporation-et-al-withdrawal-of-approval-of-five-new-drug-applications.