{"abstract":"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longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/03/21/2024-05982.html","cfr_references":[],"citation":"89 FR 20223","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of April 22, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-0644"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-03-21T09:58:07.622-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-0644-0001","allow_late_comments":null,"id":"FDA-2024-N-0644-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-0644","title":"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"}],"document_number":"2024-05982","effective_on":null,"end_page":20224,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/21/2024-05982.xml","html_url":"https://www.federalregister.gov/documents/2024/03/21/2024-05982/eli-lilly-and-company-withdrawal-of-approval-of-sarafem-fluoxetine-hydrochloride-capsules-equivalent","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-05982?publication_date=2024-03-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-21/2024-05982/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2886,"last_updated":"2026-09-21 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-21/pdf/2024-05982.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-05982.pdf?1710938722","publication_date":"2024-03-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/21/2024-05982.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-0644","supporting_documents_count":0,"docket_id":"FDA-2024-N-0644","document_id":"FDA-2024-N-0644-0001","regulation_id_number":null,"title":"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","checked_regulationsdotgov_at":"2024-03-22T16:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20223,"subtype":null,"title":"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","toc_doc":"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","toc_subject":"Withdrawal of Approval of Drug Application:\n","topics":[],"type":"Notice","volume":89}