{"description":"Documents matching 'liraglutide'","count":17,"total_pages":1,"results":[{"title":"Hazardous Drugs: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 and Final Reevaluation Determinations for Liraglutide and Pertuzumab","type":"Notice","abstract":"The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the publication of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, as well as final reevaluation determinations removing the drugs liraglutide and pertuzumab from the NIOSH List of Hazardous Drugs in Healthcare Settings.","document_number":"2024-30456","html_url":"https://www.federalregister.gov/documents/2024/12/20/2024-30456/hazardous-drugs-niosh-list-of-hazardous-drugs-in-healthcare-settings-2024-and-final-reevaluation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-20/pdf/2024-30456.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30456.pdf?1734615932","publication_date":"2024-12-20","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":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"were made to the \n NIOSH Final Reevaluation Determination of <span class=\"match\">Liraglutide</span> on the NIOSH List of Hazardous Drugs in Healthcare Settings \n based on this comment.\n \n \n b. Are the assumptions about the potential occupational exposures to <span class=\"match\">liraglutide</span> in a healthcare setting reasonable? Please explain. \n \n \n Reviewer 1 comment: \n “The assumptions about the potential occupational exposures to <span class=\"match\">liraglutide</span> in a healthcare setting are reasonable. Given the formulation and packaging of <span class=\"match\">liraglutide</span>, it would be expected that occupational exposure may occur if"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","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"}],"excerpts":" 57 \n  See Docket No. FDA-2015-N-3469, document no. FDA-2015-N-3469-0391.\n \n \n \n <span class=\"match\">Liraglutide</span> is an active ingredient in FDA-approved drug products: 18 mg/3 mL (6 mg/mL) solution for SC injection (Saxenda, NDA 206321); 18 mg/3 mL (6 mg/mL) solution for SC injection (Victoza, NDA 022341); and 18 mg/3 mL (6 mg/mL) solution for SC injection (<span class=\"match\">liraglutide</span> 18 mg/3 mL, \n e.g., \n ANDA 215503). Each FDA-approved <span class=\"match\">liraglutide</span> product contains propylene glycol.\n \n \n <span class=\"match\">Liraglutide</span> was nominated and evaluated for the SC injection route of administration in strengths"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act\" that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","document_number":"2026-12937","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12937.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12937.pdf?1782391517","publication_date":"2026-06-26","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"}],"excerpts":"Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that appeared in the \n Federal Register \n of May 1, 2026. In the \n Federal Register \n notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or <span class=\"match\">liraglutide</span> on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). The Agency is taking this action in response to a request for an extension to allow interested"},{"title":"Request for Public Comment on NIOSH Initial Recommendations To Change the Status of Liraglutide and Pertuzumab on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings","type":"Notice","abstract":"The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), requests public comment on two draft reevaluations with initial recommendations to change the status of two drugs, liraglutide and pertuzumab, on the NIOSH List of Antineoplastics and Other Hazardous Drugs in Healthcare Settings (List). The reevaluations were developed based on the process described in the NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings. Based on the reevaluations, the NIOSH initial recommendations are to remove liraglutide and pertuzumab from the List.","document_number":"2024-00693","html_url":"https://www.federalregister.gov/documents/2024/01/16/2024-00693/request-for-public-comment-on-niosh-initial-recommendations-to-change-the-status-of-liraglutide-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-16/pdf/2024-00693.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-00693.pdf?1705067130","publication_date":"2024-01-16","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":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"workplaces. \n NIOSH reevaluated the placement of <span class=\"match\">liraglutide</span> on the NIOSH List in response to a request for reevaluation from the manufacturer. Based on this reevaluation, the initial NIOSH recommendation is to remove <span class=\"match\">liraglutide</span> from the NIOSH List. In its reevaluation NIOSH determined that, due to the intrinsic molecular properties of <span class=\"match\">liraglutide</span> and the nature of the specific hazard posed by exposure to <span class=\"match\">liraglutide</span>, it is not likely to pose a hazard to workers in healthcare settings. In animal studies <span class=\"match\">liraglutide</span> was reported to cause C-cell specific thyroid"},{"title":"Foreign-Trade Zone (FTZ) 202, Notification of Proposed Production Activity; PolyPeptide Laboratories Inc.; (Peptides); Torrance, California","type":"Notice","abstract":null,"document_number":"2026-14692","html_url":"https://www.federalregister.gov/documents/2026/07/21/2026-14692/foreign-trade-zone-ftz-202-notification-of-proposed-production-activity-polypeptide-laboratories-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-21/pdf/2026-14692.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14692.pdf?1784551517","publication_date":"2026-07-21","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Foreign-Trade Zones Board","name":"Foreign-Trade Zones Board","id":208,"url":"https://www.federalregister.gov/agencies/foreign-trade-zones-board","json_url":"https://www.federalregister.gov/api/v1/agencies/208","parent_id":54,"slug":"foreign-trade-zones-board"}],"excerpts":"and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via \n www.trade.gov/ftz. \n \n The proposed finished products include: <span class=\"match\">liraglutide</span>, sodium; nectin; linaclotide; and peptides (duty-free). \n The proposed foreign-status materials/components include: Fmoc-linker; phenylalanine; threonine; Fmoc-Lys(Mtt)-OH; histidine; Fmoc-Phe-Thr(Psi(Me,Me)pro)-OH; Fmoc-Leu-Ser(Psi(Me,Me)pro)-OH; pGlu-OH; diisopropylcarbodiimide;"},{"title":"Product-Specific Guidances; Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2026-15285","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15285.pdf?1785242713","publication_date":"2026-07-29","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"}],"excerpts":"following active ingredients: \n \n Table 1—Revised Draft Product-Specific Guidances for Drug Products \n \n Active ingredient(s) \n \n \n Calcitonin salmon (multiple reference listed drugs). \n \n \n Dasiglucagon hydrochloride. \n \n \n Glucagon (multiple reference listed drugs). \n \n \n <span class=\"match\">Liraglutide</span> (multiple reference listed drugs). \n \n \n Pegcetacoplan (multiple reference listed drugs). \n \n \n Semaglutide (multiple reference listed drugs). \n \n \n Teriparatide (multiple reference listed drugs). \n \n \n Tirzepatide (multiple reference listed drugs). \n \n \n Vosoritide. \n"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2025-22131","html_url":"https://www.federalregister.gov/documents/2025/12/05/2025-22131/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-05/pdf/2025-22131.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22131.pdf?1764855937","publication_date":"2025-12-05","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"}],"excerpts":"Dasiglucagon hydrochloride \n \n \n Diltiazem hydrochloride \n \n \n Epinephrine (multiple reference listed drugs) \n \n \n Etodolac \n \n \n Fluticasone propionate \n \n \n Glucagon (multiple reference listed drugs) \n \n \n Hydrochlorothiazide; Metoprolol tartrate \n \n \n Ixazomib \n \n \n <span class=\"match\">Liraglutide</span> (multiple reference listed drugs) \n \n \n Mesalamine \n \n \n Omeprazole; Sodium bicarbonate \n \n \n Pegcetacoplan (multiple reference listed drugs) \n \n \n Poscaconazole \n \n \n Pyridostigmine bromide \n \n \n Semaglutide \n \n \n Sunitinib malate \n \n \n Tapinarof \n \n \n Teriparatide \n "},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2024-27048","html_url":"https://www.federalregister.gov/documents/2024/11/20/2024-27048/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-20/pdf/2024-27048.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27048.pdf?1732023938","publication_date":"2024-11-20","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"}],"excerpts":"carboxymaltose. \n \n \n Ferumoxytol. \n \n \n Fluticasone propionate. \n \n \n Fluticasone propionate; Salmeterol xinafoate. \n \n \n Formoterol fumarate. \n \n \n Formoterol fumarate; Mometasone furoate. \n \n \n Labetalol hydrochloride. \n \n \n Lenvatinib mesylate. \n \n \n Levonorgestrel. \n \n \n <span class=\"match\">Liraglutide</span>. \n \n \n Losartan potassium. \n \n \n Mometasone furoate. \n \n \n Nepafenac (multiple reference listed drugs). \n \n \n Nitroglycerin. \n \n \n Olaparib. \n \n \n Phytonadione (multiple reference listed drugs). \n \n \n Primidone. \n \n \n Rasagiline mesylate. \n \n \n Ruxolitinib phosphate. \n"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2024-10896","html_url":"https://www.federalregister.gov/documents/2024/05/17/2024-10896/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-17/pdf/2024-10896.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-10896.pdf?1715863532","publication_date":"2024-05-17","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"}],"excerpts":"Ingredient(s) \n \n \n Atorvastatin calcium \n \n \n Baclofen \n \n \n Bexagliflozin \n \n \n Daprodustat \n \n \n Elacestrant dihydrochloride \n \n \n Gadopiclenol \n \n \n Ganciclovir \n \n \n Ganirelix acetate \n \n \n Indomethacin \n \n \n Lacosamide \n \n \n Levodopa \n \n \n Lidocaine hydrochloride \n \n \n <span class=\"match\">Liraglutide</span> recombinant \n \n \n \n Lotilaner \n \n \n Nalmefene hydrochloride \n \n \n Omaveloxolone \n \n \n Oxazepam \n \n \n Pegcetacoplan \n \n \n Perfluorohexyloctane \n \n \n Pirtobrutinib \n \n \n Rezafungin acetate \n \n \n Sodium oxybate \n \n \n Sparsentan \n \n \n Tasimelteon \n \n \n Tobramycin \n \n \n Zavegepant"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.","document_number":"2020-04320","html_url":"https://www.federalregister.gov/documents/2020/03/03/2020-04320/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-03/pdf/2020-04320.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04320.pdf?1583156728","publication_date":"2020-03-03","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"}],"excerpts":"hydrochloride; Saxagliptin hydrochloride. \n \n \n Diltiazem hydrochloride. \n \n \n Doravirine. \n \n \n Doravirine; Lamivudine; Tenofovir disoproxil fumarate. \n \n \n Duloxetine hydrochloride. \n \n \n Edaravone. \n \n \n Elagolix sodium. \n \n \n Granisetron. \n \n \n Ivacaftor; Lumacaftor. \n \n \n <span class=\"match\">Liraglutide</span> recombinant. \n \n \n Lusutrombopag. \n \n \n Mexiletine hydrochloride. \n \n \n Moxidectin. \n \n \n Propranolol hydrochloride. \n \n \n Rifamycin sodium. \n \n \n Selenious acid. \n \n \n Semaglutide. \n \n \n Stiripentol (multiple reference listed drugs). \n \n \n Sumatriptan succinate. \n \n \n"},{"title":"Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.\" The Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the FDA an abbreviated new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA).","document_number":"2017-21202","html_url":"https://www.federalregister.gov/documents/2017/10/03/2017-21202/abbreviated-new-drug-applications-for-certain-highly-purified-synthetic-peptide-drug-products-that","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21202.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-21202.pdf?1506948356","publication_date":"2017-10-03","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"}],"excerpts":"new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, <span class=\"match\">liraglutide</span>, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA). \n \n \n DATES: \n Submit either electronic or"},{"title":"Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2017-10326","html_url":"https://www.federalregister.gov/documents/2017/05/22/2017-10326/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting-establishment-of-a-public","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-05-22/pdf/2017-10326.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-10326.pdf?1495197957","publication_date":"2017-05-22","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"}],"excerpts":"brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.\n \n \n Agenda: \n The committee will discuss a supplemental new drug application for VICTOZA (<span class=\"match\">liraglutide</span>) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: As an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction"},{"title":"Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"2016-05959","html_url":"https://www.federalregister.gov/documents/2016/03/17/2016-05959/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-17/pdf/2016-05959.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-05959.pdf?1458132336","publication_date":"2016-03-17","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"}],"excerpts":"advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.\n \n \n Agenda: \n The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and <span class=\"match\">liraglutide</span> injection, submitted by Novo Nordisk Inc., for the proposed indication: Adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus.\n \n \n FDA intends to make background material available to the public no later than"},{"title":"Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"2014-18304","html_url":"https://www.federalregister.gov/documents/2014/08/04/2014-18304/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-04/pdf/2014-18304.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-18304.pdf?1406897339","publication_date":"2014-08-04","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"}],"excerpts":"link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.\n \n \n Agenda: \n The committee will discuss the safety and efficacy of new drug application (NDA) 206321, <span class=\"match\">liraglutide</span> for injection, sponsored by Novo Nordisk, Inc. The proposed indication for <span class=\"match\">liraglutide</span> is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m\n 2 \n ) or greater, or with"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza","type":"Notice","abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for Victoza and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.","document_number":"2012-10517","html_url":"https://www.federalregister.gov/documents/2012/05/02/2012-10517/determination-of-regulatory-review-period-for-purposes-of-patent-extension-victoza","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-05-02/pdf/2012-10517.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-10517.pdf?1335876632","publication_date":"2012-05-02","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"}],"excerpts":"was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). \n FDA recently approved for marketing the human drug product VICTOZA (<span class=\"match\">liraglutide</span> (rDNA origin)). VICTOZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for Victoza (U.S. Patent"},{"title":"Government-Owned Inventions; Availability for Licensing","type":"Notice","abstract":"The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.","document_number":"2012-9776","html_url":"https://www.federalregister.gov/documents/2012/04/24/2012-9776/government-owned-inventions-availability-for-licensing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-04-24/pdf/2012-9776.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-09776.pdf?1335185717","publication_date":"2012-04-24","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":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"of Acute and Chronic Neurological Disorders Using GLP-1, Exendin-4 and Analogs \n \n Description of Technology: \n Glucagon-like peptide-1 (GLP-1) and related peptides, including exendin-4 and <span class=\"match\">liraglutide</span>, are incretin mimetics that enhance glucose-dependent insulin secretion following food ingestion as a regulator of glucose homeostasis. Exendin-4 and <span class=\"match\">liraglutide</span> are used clinically in the safe and effective treatment of type 2 diabetes to enhance insulin secretion and maintain a euglycemic state. These actions are primarily mediated at the level of"},{"title":"Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"E9-5024","html_url":"https://www.federalregister.gov/documents/2009/03/10/E9-5024/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-03-10/pdf/E9-5024.pdf","public_inspection_pdf_url":null,"publication_date":"2009-03-10","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"}],"excerpts":"(NDAs), proposed for the treatment of hyperglycemia in adults with type 2 diabetes mellitus will be discussed. On April 1, 2009, the committee will discuss NDA 22-350, saxagliptin tablets, Bristol-Myers Squibb, and on April 2, 2009, the committee will discuss NDA 22-341, <span class=\"match\">liraglutide</span> injection, Novo Nordisk, Inc.\n \n \n FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made"}]}