Elevar Therapeutics, Inc. · NDA 216586

ind U.S. FOOD & DRUG ADMINISTRATION q NDA 216586 COMPLETE RESPONSE Elevar Therapeutics, Inc. Attention: Young-Sil (Anna) Yim Senior Director, Regulatory Affairs One Bridge Plaza, Suite 850 Fort Lee, NJ 07024 Dear Young-Sil (Anna) Yim: (b) (4) (b) (4) Please refer to your , new drug application for ®® _ (rivoceranib) tablets. (b) (4) We acknowledge receipt of your , amendment, which constituted a complete response to our oe , action letter. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. (1) Because the safety and effectiveness of |’) (rivoceranib) has only been established in combination with SHR-1210, we will not approve rivoceranib until a regulatory approval action is issued for SHR-1210. PRESCRIBING INFORMATION (2) We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the Prescription Drug Labeling Resources’ and Pregnancy and Lactation Labeling Final Rule? websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) — a checklist of important format items from labeling regulations and guidances. If you revise labeling, use the SRPI checklist to ensure that the Prescribing Information conforms with format items in regulations and guidances. Your 1 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources 2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs- final-rule Reference ID: 5553216 NDA 216586 Page 2 response must include updated content of labeling [21 CFR 314.50(I)(1)(i)] in structured product labeling (SPL) format as described at FDA.gov.? CARTON AND CONTAINER LABELING (3) We reserve comment on the proposed labeling until the application is otherwise adequate. PROPRIETARY NAME (b) (4) (b) (4) Please refer to your correspondence dated, , and our ; correspondence which addresses the proposed proprietary name,) ~—_—. This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies that have been identified in this letter. OTHER Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 314.65. You may also request an extension of time in which to resubmit the application. A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION' in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle. You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. The product may not be legally marketed until you have been notified in writing that this application is approved. 3 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov Reference ID: 5553216 NDA 216586 Page 3 Sincerely, {See appended electronic signature page} Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov Reference ID: 5553216 Signature Page 1 of 1 This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. wa) 03/20/2025 09:54:52 AM Reference ID: 5553216