{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that STRATTERA (atomoxetine hydrochloride) capsules 5 milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","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/2026/04/06/2026-06661.html","cfr_references":[],"citation":"91 FR 17285","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-6868"],"dockets":[{"supporting_documents":[{"title":"Attachment 2 - Eli Lilly and Co. (2022). United States Prescribing Information for Strattera (atomoxetine hydrochloride) capsules, for oral use (NDA 021411)","document_id":"FDA-2025-P-6868-0004"},{"title":"Attachment 1 - CP Authorization Letter - signed","document_id":"FDA-2025-P-6868-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-04-06","updated_at":"2026-04-06T17:56:28.421-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-6868-0007","allow_late_comments":false,"id":"FDA-2025-P-6868-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2025-P-6868","title":"Requests that the FDA make a determination that the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Co were not discontinued due to safety or efficacy reasons"}],"document_number":"2026-06661","effective_on":null,"end_page":17286,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/06/2026-06661.xml","html_url":"https://www.federalregister.gov/documents/2026/04/06/2026-06661/determination-that-strattera-atomoxetine-hydrochloride-capsules-5-milligrams-10-milligrams-18","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-06661?publication_date=2026-04-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-06/2026-06661/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":368,"last_updated":"2026-06-21 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-06/pdf/2026-06661.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06661.pdf?1775220318","publication_date":"2026-04-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/06/2026-06661.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 2 - Eli Lilly and Co. (2022). United States Prescribing Information for Strattera (atomoxetine hydrochloride) capsules, for oral use (NDA 021411)","document_id":"FDA-2025-P-6868-0004"},{"title":"Attachment 1 - CP Authorization Letter - signed","document_id":"FDA-2025-P-6868-0003"}],"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-2025-P-6868","supporting_documents_count":2,"docket_id":"FDA-2025-P-6868","document_id":"FDA-2025-P-6868-0007","regulation_id_number":null,"title":"Requests that the FDA make a determination that the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Co were not discontinued due to safety or efficacy reasons","checked_regulationsdotgov_at":"2026-04-07T17:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17285,"subtype":null,"title":"Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams","toc_subject":"Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}