{"description":"Documents matching 'metreleptin'","count":3,"total_pages":1,"results":[{"title":"NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018","type":"Notice","abstract":"The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability for public comment on the drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.","document_number":"2018-02957","html_url":"https://www.federalregister.gov/documents/2018/02/14/2018-02957/niosh-list-of-antineoplastic-and-other-hazardous-drugs-in-healthcare-settings-proposed-additions-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-02-14/pdf/2018-02957.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-02957.pdf?1518529545","publication_date":"2018-02-14","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":"in Table 3.\n \n \n Table 3—Available Toxicity Information Does Not Demonstrate or Support a Determination That the Drug Meets the NIOSH Definition of a Hazardous Drug \n [Category 4] \n \n   \n   \n   \n \n \n Aglucosidase \n Diazoxide \n Lanreotide \n \n \n Alectinib \n Elotuzumab \n <span class=\"match\">Metreleptin</span> \n \n \n Alendronate \n Finafloxacin \n Milnacipran \n \n \n Alogliptin \n Golimumab \n Nintedanib \n \n \n Apremilast \n Idelalisib \n Peginterferon beta-1A \n \n \n Calcipotriene \n Isavuconazonium \n Pirfenidone \n \n \n Cetuximab \n Itraconazole \n Tasimelteon \n \n \n Clarithromycin \n Lamotrigine"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT","type":"Notice","abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for MYALEPT 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.","document_number":"2016-22935","html_url":"https://www.federalregister.gov/documents/2016/09/23/2016-22935/determination-of-regulatory-review-period-for-purposes-of-patent-extension-myalept","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-23/pdf/2016-22935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-22935.pdf?1474548357","publication_date":"2016-09-23","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":"issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). \n FDA has approved for marketing the human biologic product MYALEPT (<span class=\"match\">metreleptin</span>). MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Subsequent to this approval, the USPTO received two patent term restoration applications"},{"title":"Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"2013-25588","html_url":"https://www.federalregister.gov/documents/2013/10/30/2013-25588/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-10-30/pdf/2013-25588.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-25588.pdf?1383050940","publication_date":"2013-10-30","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":"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 biologic license application (BLA) 125390, <span class=\"match\">metreleptin</span> for injection, sponsored by Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of Bristol-Myers Squibb. The proposed indication for <span class=\"match\">metreleptin</span> is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia (elevated triglyceride levels in the blood) in pediatric and adult patients"}]}