Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writi...
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of August 5, 2026.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-796-3137,
Kimberly.Lehrfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Reyvow (lasmiditan succinate) Tablets, EQ 50 mg base, EQ 100 mg base, and EQ 200 mg base
Eli Lilly and Company, Lilly Corporate Center, Drop Code 2543, Indianapolis, IN 46285.
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of August 5, 2026. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on August 5, 2026 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
Use this for formal legal and research references to the published document.
91 FR 41045
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications,” thefederalregister.org (July 6, 2026), https://thefederalregister.org/documents/2026-13616/endo-operations-limited-et-al-withdrawal-of-approval-of-34-new-drug-applications.
21 CFR 314.150(c)
21 U.S.C. 355(a)