{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended- release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg and 20 mg.","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/2021/03/04/2021-04449.html","cfr_references":[],"citation":"86 FR 12697","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0030"],"dockets":[],"document_number":"2021-04449","effective_on":null,"end_page":12698,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/04/2021-04449.xml","html_url":"https://www.federalregister.gov/documents/2021/03/04/2021-04449/determination-that-belviq-lorcaserin-hydrochloride-tablets-10-milligrams-and-belviq-xr-lorcaserin","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-04449?publication_date=2021-03-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-04/2021-04449/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1953,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-04/pdf/2021-04449.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-04449.pdf?1614779133","publication_date":"2021-03-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/04/2021-04449.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-2021-N-0030","supporting_documents_count":0,"docket_id":"FDA-2021-N-0030","document_id":"FDA-2021-N-0030-0001","regulation_id_number":null,"title":"Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, And BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness","checked_regulationsdotgov_at":"2021-03-05T04:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12697,"subtype":null,"title":"Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams","toc_subject":"Withdrawal of Drug Products From Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":86}