{"abstract":"The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, 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/2013/03/04/2013-04827.html","cfr_references":[],"citation":"78 FR 14095","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-P-1071"],"dockets":[],"document_number":"2013-04827","effective_on":null,"end_page":14096,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/03/04/2013-04827.xml","html_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-04827?publication_date=2013-03-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-03-04/2013-04827/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":12110,"last_updated":"2026-10-25 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-04827.pdf?1362145737","publication_date":"2013-03-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/03/04/2013-04827.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-2012-P-1071","supporting_documents_count":0,"docket_id":"FDA-2012-P-1071","regulation_id_number":null,"title":"Determine Whether NDA No. N020443 for Geref (Sermorlin Acetate) Was Withdrawn for Safety and Efficacy Reasons","checked_regulationsdotgov_at":"2013-03-24T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14095,"subtype":null,"title":"Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp","toc_subject":"Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":78}