United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2024_register executive 2024-03-21 article Notices D09002ee1c79269d6 D09002ee1c7926a65 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn. 89 FR 20223 https://www.govinfo.gov/app/details/FR-2024-03-21/2024-05982 2024-05982 fr21mr24-57 4164-01-P Docket No. FDA-2024-N-0644 https://www.govinfo.gov/app/details/FR-2024-03-21/2024-05982 https://www.govinfo.gov/content/pkg/FR-2024-03-21/html/2024-05982.htm https://www.govinfo.gov/content/pkg/FR-2024-03-21/pdf/2024-05982.pdf 2 p. 20223 20224 89 FR 20223 Eli Lilly and Company; Withdrawal of Approval of SARAFEM (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication Approved Under New Drug Application 018936; Federal Register Vol. 89, Issue NOTICE 2024-05982 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2024-N-0644 4164-01-P 2024-05982 Notice.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.

Approval is withdrawn as of April 22, 2024. Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301- 796-3137, Kimberly.Lehrfeld@fda.hhs.gov. Withdrawal of Approval of Drug Application: Eli Lilly and Co.; Sarafem (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication, Kimberly.Lehrfeld@fda.hhs.gov Vol. 89, no. 56 Office of the Federal Register, National Archives and Records Administration 2024-03-21 continuing daily deposited born digital 219 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2024-03-21 P0b002ee1c5c6ff4d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21mr24 https://www.govinfo.gov/app/details/FR-2024-03-21 https://www.govinfo.gov/content/pkg/FR-2024-03-21/pdf/FR-2024-03-21.pdf https://www.govinfo.gov/content/pkg/FR-2024-03-21/xml/FR-2024-03-21.xml fdlp 20093 20301 DGPO 2024-03-21 2024-05-28 FR-2024-03-21 machine generated eng FR FR-2024-03-21 89 56