Complete Response Letters
AOP Orphan Pharmaceuticals GmbH: landiolol
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 31, 2023
Federal Food, Drug, and Cosmetic Act for landiolol injection.
CRL_NDA217202_20230531:p1:s14We acknowledge the draft labeling you submitted on March 15, 2023. We reserve further comment on your labeling until your application is otherwise acceptable.
CRL_NDA217202_20230531:p1:s23Section 505(0)(3) of the FDCA authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute.
CRL_NDA217202_20230531:p2:s19Our finding is that you have not investigated the inhibitory effect of landiolol and its metabolite M1 on the activity of multiple drug transporters.
CRL_NDA217202_20230531:p2:s20Based on the above, FDA has determined that if NDA 217202 is approved, an analysis of spontaneous postmarketing adverse events reported under subsection 505(k)(1) of he FDCA will not be sufficient to assess a signal of a serious risk of these potential drug interactions.
CRL_NDA217202_20230531:p2:s22217202 is approved, you will be required to:
CRL_NDA217202_20230531:p2:s25More Complete Response Letters
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