ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing

摘要

The Food and Drug Administration's (FDA, Agency, or we) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of the new drug application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320 (ChemoCentryx or applicant), and is announcing an opportunity for the applicant to request a hearing on this proposal. The grounds for the proposal are twofold: (i) on the basis of new information before FDA, evaluated together with the evidence available to FDA when the application was approved, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling; and (ii) the application contains untrue statements of material fact.