{"description":"Documents matching 'teduglutide'","count":5,"total_pages":1,"results":[{"title":"Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to the FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2024-16618","html_url":"https://www.federalregister.gov/documents/2024/07/29/2024-16618/pediatric-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-29/pdf/2024-16618.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16618.pdf?1721997931","publication_date":"2024-07-29","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":"CLEOCIN PHOSPHATE (clindamycin phosphate), CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (clindamycin phosphate), CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE (clindamycin phosphate) \n f. DYANAVEL XR (amphetamine) \n g. EVEKEO ODT (amphetamine sulfate) \n h. GATTEX (<span class=\"match\">teduglutide</span>) \n i. GILENYA (fingolimod) and TASCENSO ODT (fingolimod) \n j. JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin HCl), JANUMET XR (sitagliptin/metformin hydrochloride extended release) \n k. KAPSPARGO SPRINKLE (metoprolol succinate extended release) \n l. LITHIUM (lithium"},{"title":"Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders","type":"Proposed Rule","abstract":"We propose to revise the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving digestive and skin disorders in adults and children under titles II and XVI of the Social Security Act (Act). The proposed revisions reflect our adjudicative experience, advances in medical knowledge, and comments we received from experts and the public in response to two advance notices of proposed rulemaking (ANPRM).","document_number":"2019-15554","html_url":"https://www.federalregister.gov/documents/2019/07/25/2019-15554/revised-medical-criteria-for-evaluating-digestive-disorders-and-skin-disorders","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-07-25/pdf/2019-15554.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-15554.pdf?1563972314","publication_date":"2019-07-25","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"S. (2013). Model for end-stage liver disease. \n Journal of Clinical and Experimental Hepatology, 3 \n (1), 50-60. doi:10.1016/j.jceh.2012.11.002.\n \n \n Tee, C.T., Wallis, K., &amp; Gabe, S.M. (2011). Emerging treatment options for short bowel syndrome: Potential role of <span class=\"match\">teduglutide</span>. \n Clinical and Experimental Gastroenterology, 4, \n 189-196. doi:10.2147/CEG.S13906.\n \n \n Vuachet, D., Cervoni, J., Vuitton, L., Weil, D., Dritsas, S., Dussaucy, A., . . . Thevenot, T. (2015). Improved survival of cirrhotic patients with variceal bleeding over the decade"},{"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":"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 <span class=\"match\">teduglutide</span>) 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 written comments on the draft guidance by December"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; GATTEX","type":"Notice","abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for GATTEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 drug product.","document_number":"2015-11000","html_url":"https://www.federalregister.gov/documents/2015/05/07/2015-11000/determination-of-regulatory-review-period-for-purposes-of-patent-extension-gattex","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-05-07/pdf/2015-11000.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-11000.pdf?1430916379","publication_date":"2015-05-07","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":"patent 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 has approved for marketing the human drug product GATTEX (<span class=\"match\">teduglutide</span> [rDNA origin]). GATTEX is indicated for treatment of adult patients with Short Bowel Syndrome who are dependent on parenteral support. Subsequent to this approval, the USPTO received patent term restoration applications for GATTEX (U.S. Patent Nos. 5,789,379 and 7,056,886)"},{"title":"Gastrointestinal Drugs Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"2012-20612","html_url":"https://www.federalregister.gov/documents/2012/08/22/2012-20612/gastrointestinal-drugs-advisory-committee-notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-08-22/pdf/2012-20612.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-20612.pdf?1345553517","publication_date":"2012-08-22","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":"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) 203441, with the proposed trade name GATTEX (<span class=\"match\">teduglutide</span>) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome.\n \n \n FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA"}]}