{"description":"Documents matching 'albiglutide'","count":2,"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":"\n Rasagiline \n \n \n Aclidinium \n Dexlansoprazole \n Lamivudine \n Regadenosone \n \n \n Adalimumab \n Diclofenac \n Lansoprazole \n Rifaximin \n \n \n Adenosine \n Diltiazem \n Ledipasvir/Sofosbuvir \n Rilpivirine \n \n \n Aflibercept \n Dimethyl fumarate \n Lesinurad \n Risedronate \n \n \n <span class=\"match\">Albiglutide</span> \n Dolasetron \n Levetiracetam \n Rivaroxaban \n \n \n Alcaftadine \n Doripenem \n Levomilnacipran \n Rivastigmine \n \n \n Alirocumab \n Doxazosin \n Linaclotide \n Rocuronium \n \n \n Almotriptan \n Doxepin \n Linagliptin \n Rolapitant \n \n \n Anagrelide \n Doxycycline \n Lincomycin \n Ropinirole"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM","type":"Notice","abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for TANZEUM 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":"2016-13797","html_url":"https://www.federalregister.gov/documents/2016/06/10/2016-13797/determination-of-regulatory-review-period-for-purposes-of-patent-extension-tanzeum","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-10/pdf/2016-13797.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-13797.pdf?1465476613","publication_date":"2016-06-10","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":"issued), FDA's determination of the \n \n 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 \n FDA has approved for marketing the human biological product TANZEUM (<span class=\"match\">albiglutide</span>). TANZEUM 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 U.S. Patent and Trademark Office (USPTO) received a patent term restoration application for TANZEUM (U.S. Patent"}]}