{"abstract":"The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ZECUITY (sumatriptan iontophoretic transdermal system) held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. Teva requested withdrawal of this application and has waived its opportunity for a hearing.","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/2020/07/02/2020-14284.html","cfr_references":[],"citation":"85 FR 39913","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of July 2, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1360"],"dockets":[],"document_number":"2020-14284","effective_on":null,"end_page":39913,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/02/2020-14284.xml","html_url":"https://www.federalregister.gov/documents/2020/07/02/2020-14284/teva-branded-pharmaceutical-products-randd-inc-withdrawal-of-approval-of-a-new-drug-application-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-14284?publication_date=2020-07-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-02/2020-14284/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":994,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-02/pdf/2020-14284.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-14284.pdf?1593607534","publication_date":"2020-07-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/02/2020-14284.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1360","supporting_documents_count":0,"docket_id":"FDA-2020-N-1360","regulation_id_number":null,"title":"Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (sumatriptan iontophoretic transdermal system)","checked_regulationsdotgov_at":"2020-07-05T03:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39913,"subtype":null,"title":"Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System)","toc_doc":"ZECUITY (sumatriptan iontophoretic transdermal system); Teva Branded Pharmaceutical Products R and D, Inc.","toc_subject":"Withdrawal of Approval of a New Drug Application:\n","topics":[],"type":"Notice","volume":85}