Home › Recently closed › 2026-08455
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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.
- Document type
- Notice
- Federal Register document number
- 2026-08455
- Published
- Apr 30, 2026
- Action
- Notice.
- Docket
- FDA-2026-N-1321
- Comments posted on Regulations.gov (at last check)
- 120
- DATES section (from the document)
- The applicant may submit a written request for a hearing by June 1, 2026 and submit all data, information, and analyses in support of the hearing request by June 29, 2026. Others may submit electronic or written comments by June 29, 2026.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-08455. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.