{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met.","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/2016/08/02/2016-18139.html","cfr_references":[],"citation":"81 FR 50710","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2016-P-0974"],"dockets":[],"document_number":"2016-18139","effective_on":null,"end_page":50711,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/02/2016-18139.xml","html_url":"https://www.federalregister.gov/documents/2016/08/02/2016-18139/determination-that-samsca-tolvaptan-tablets-60-milligrams-were-not-withdrawn-from-sale-for-reasons","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-18139?publication_date=2016-08-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-02/2016-18139/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":534,"last_updated":"2026-04-04 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-02/pdf/2016-18139.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-18139.pdf?1470055523","publication_date":"2016-08-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/02/2016-18139.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment B Electronic Orange Book for Tolvaptan 60 MG Samsca Otsuka America Pharm re Citizen Petition from Gordon Johnston Regulatory Consultants LLC","document_id":"FDA-2016-P-0974-0004"},{"title":"Attachment A Electronic Orange Book TOLVAPTAN TABLET; ORAL 15MG 30MG SAMSCA OTSUKA AMERICA PHARM re Citizen Petition from Gordon Johnston Regulatory Consultants LLC","document_id":"FDA-2016-P-0974-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-P-0974","supporting_documents_count":2,"docket_id":"FDA-2016-P-0974","regulation_id_number":null,"title":"Petitioner requests that the Commissioner of the Food and Drug Administration determine whether SAMSCA (Tolvaptan) Tablets, 60 mg, (NDA 022275) held by Otsuka America Pharma has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy","checked_regulationsdotgov_at":"2016-08-22T06:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50710,"subtype":null,"title":"Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"SAMSCA (Tolvaptan) Tablets, 60 Milligrams","toc_subject":"Determinations That Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":81}