{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, 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/2021/05/20/2021-10593.html","cfr_references":[],"citation":"86 FR 27436","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2021-P-0226"],"dockets":[],"document_number":"2021-10593","effective_on":null,"end_page":27437,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/20/2021-10593.xml","html_url":"https://www.federalregister.gov/documents/2021/05/20/2021-10593/determination-that-avaclyr-acyclovir-ophthalmic-ointment-3-percent-was-not-withdrawn-from-sale-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10593?publication_date=2021-05-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-20/2021-10593/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1768,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10593.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10593.pdf?1621428324","publication_date":"2021-05-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/20/2021-10593.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-P-0226","supporting_documents_count":0,"docket_id":"FDA-2021-P-0226","document_id":"FDA-2021-P-0226-0003","regulation_id_number":null,"title":"Requesting that the FDA  determine whether FERA PHARMACEUTICALS LLC, USA RLD AVACLYR (Acyclovir) Ophthalmic ointment 3% (30 mg/g) approved under NDA 202408 was withdrawn for safety and/or effectiveness reasons and to designate an additional RLD; CLOSED","checked_regulationsdotgov_at":"2021-05-21T03:30:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27436,"subtype":null,"title":"Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"AVACLYR (Acyclovir Ophthalmic Ointment), 3 Percent","toc_subject":"Withdrawal of Drug Products from Sale for Reasons other than Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":86}