{"description":"Documents matching 'semaglutide' and from Food and Drug Administration","count":13,"total_pages":1,"results":[{"title":"Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) has determined that OZEMPIC (semaglutide) solution, 2 milligrams (mg)/1.5 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","document_number":"2026-08435","html_url":"https://www.federalregister.gov/documents/2026/04/30/2026-08435/determination-that-ozempic-semaglutide-solution-2-milligrams-per-15-milliliters-was-not-withdrawn","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-30/pdf/2026-08435.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08435.pdf?1777466717","publication_date":"2026-04-30","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":"based on the information we have at this time, FDA has determined under § 314.161 that OZEMPIC (<span class=\"match\">semaglutide</span>) solution, 2 mg/1.5 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that OZEMPIC (<span class=\"match\">semaglutide</span>) solution, 2 mg/1.5 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of OZEMPIC (<span class=\"match\">semaglutide</span>) solution, 2 mg/1.5 mL, from sale. We have also independently evaluated relevant literature"},{"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":"formulations of <span class=\"match\">semaglutide</span>, <span class=\"match\">semaglutide</span> C and <span class=\"match\">semaglutide</span> D, compared to <span class=\"match\">semaglutide</span> MPI \n 60 \n \n This article, which did not evaluate liraglutide, does not appear to support the nominator's position. The article does not, as the nominator claims, find that “95% of patients preferred the formulation without propylene glycol.” When comparing <span class=\"match\">semaglutide</span> D, the formulation that did not contain propylene glycol, with <span class=\"match\">semaglutide</span> MPI, a formulation that contains propylene glycol, the authors concluded that “[t]he injection-site experience with <span class=\"match\">semaglutide</span> D was"},{"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":"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 \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 <span class=\"match\">semaglutide</span>, 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"},{"title":"Jeremy Spencer Brown: Final Debarment Order","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeremy Spencer Brown for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Brown was convicted of one felony count under Federal law for introduction of unapproved drugs into interstate commerce with intent to defraud or mislead. The factual basis supporting Mr. Brown's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Brown was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 21, 2025 (30 days after receipt of the notice), Mr. Brown had not responded. Mr. Brown's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.","document_number":"2026-02786","html_url":"https://www.federalregister.gov/documents/2026/02/12/2026-02786/jeremy-spencer-brown-final-debarment-order","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02786.pdf?1770817507","publication_date":"2026-02-12","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":"also offered for sale through his company's websites Viagra-Max Sildenafil and Cialis-Max Tadalafil, which were unapproved versions of the prescription drugs Viagra and Cialis. In addition, Mr. Brown also offered for sale an unapproved version of drug products containing <span class=\"match\">semaglutide</span>, the active pharmaceutical ingredient in the FDA approved prescription drugs Ozempic, Wegovy, and Rybelsus. None of the drugs Mr. Brown sold through his website was approved by FDA. Mr. Brown included on his websites disclaimers that he knew were false and misleading, including"},{"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":"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 Liraglutide (multiple reference listed drugs). \n \n \n Pegcetacoplan (multiple reference listed drugs). \n \n \n <span class=\"match\">Semaglutide</span> (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 \n \n \n For a complete history of previously published \n Federal Register \n notices related to product-specific"},{"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":"Hydrochlorothiazide; Metoprolol tartrate \n \n \n Ixazomib \n \n \n Liraglutide (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 <span class=\"match\">Semaglutide</span> \n \n \n Sunitinib malate \n \n \n Tapinarof \n \n \n Teriparatide \n \n \n \n Tirzepatide \n \n \n Treprostinil \n \n \n Tretinoin \n \n \n Trospium chloride \n \n \n Vosoritide \n \n \n \n For a complete history of previously published \n Federal Register \n notices related to product-specific guidances"},{"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":"2026-03963","html_url":"https://www.federalregister.gov/documents/2026/02/27/2026-03963/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-27/pdf/2026-03963.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03963.pdf?1772113515","publication_date":"2026-02-27","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":"\n Imatinib mesylate. \n \n \n Landiolol hydrochloride. \n \n \n Letermovir. \n \n \n Meloxicam; Rizatriptan benzoate. \n \n \n Mometasone furoate. \n \n \n Paliperidone palmitate. \n \n \n Phenylephrine hydrochloride; Tropicamide. \n \n \n Ribavirin. \n \n \n Rilpivirine hydrochloride. \n \n \n <span class=\"match\">Semaglutide</span>. \n \n \n Sofosbuvir; Velpatasvir. \n \n \n Tadalafil. \n \n \n Testosterone cypionate (multiple reference listed drugs). \n \n \n Tolmetin sodium (multiple reference listed drugs). \n \n \n III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available \n FDA is announcing"},{"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":"2025-19345","html_url":"https://www.federalregister.gov/documents/2025/10/02/2025-19345/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-10-02/pdf/2025-19345.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19345.pdf?1759322728","publication_date":"2025-10-02","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":"(multiple reference listed drugs). \n \n \n Paliperidone palmitate. \n \n \n Penicillin G benzathine. \n \n \n Phentermine hydrochloride; Topiramate. \n \n \n Ponatinib hydrochloride. \n \n \n Posaconazole. \n \n \n Progesterone. \n \n \n Ranitidine hydrochloride. \n \n \n Risperidone. \n \n \n <span class=\"match\">Semaglutide</span>. \n \n \n Topiramate (multiple reference listed drugs). \n \n \n Torsemide. \n \n \n Trazodone hydrochloride. \n \n \n Triamcinolone acetonide. \n \n \n Umeclidinium bromide. \n \n \n Umeclidinium bromide; Vilanterol trifenatate. \n \n \n Venlafaxine hydrochloride. \n \n \n Zonisamide. \n \n \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 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":"2023-25485","html_url":"https://www.federalregister.gov/documents/2023/11/17/2023-25485/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-17/pdf/2023-25485.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25485.pdf?1700142494","publication_date":"2023-11-17","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":"(multiple reference listed drugs) \n \n \n Fingolimod lauryl sulfate \n \n \n Furosemide \n \n \n Futibatinib \n \n \n Ganaxolone \n \n \n Glycopyrrolate; Neostigmine methylsulfate \n \n \n Halobetasol propionate; Tazarotene \n \n \n \n Latanoprost \n \n \n Omidenepag isopropyl \n \n \n Risperidone \n \n \n <span class=\"match\">Semaglutide</span> \n \n \n Tapinarof \n \n \n III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available \n FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: \n \n Table"},{"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":"2021-18072","html_url":"https://www.federalregister.gov/documents/2021/08/23/2021-18072/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-08-23/pdf/2021-18072.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-18072.pdf?1629463552","publication_date":"2021-08-23","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":"Fostemsavir tromethamine \n \n \n Indomethacin \n \n \n Ipratropium bromide \n \n \n Lasmiditan succinate \n \n \n Leuprolide acetate \n \n \n Loteprednol etabonate \n \n \n Olodaterol hydrochloride \n \n \n Osilodrostat phosphate \n \n \n Ozanimod hydrochloride \n \n \n Paliperidone palmitate \n \n \n <span class=\"match\">Semaglutide</span> \n \n \n Sufentanil citrate \n \n \n Tazemetostat hydrobromide \n \n \n III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available \n FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing"},{"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":"Edaravone. \n \n \n Elagolix sodium. \n \n \n Granisetron. \n \n \n Ivacaftor; Lumacaftor. \n \n \n Liraglutide 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 <span class=\"match\">Semaglutide</span>. \n \n \n Stiripentol (multiple reference listed drugs). \n \n \n Sumatriptan succinate. \n \n \n Tacrolimus. \n \n \n Tiopronin. \n \n \n Tolvaptan. \n \n \n Umeclidinium bromide; Vilanterol trifenatate. \n \n \n Upadacitinib. \n \n \n III. Drug Products for Which Revised Draft Product-Specific"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; OZEMPIC","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OZEMPIC 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 drug product.","document_number":"2019-25850","html_url":"https://www.federalregister.gov/documents/2019/11/29/2019-25850/determination-of-regulatory-review-period-for-purposes-of-patent-extension-ozempic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-29/pdf/2019-25850.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-25850.pdf?1574862321","publication_date":"2019-11-29","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":"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 OZEMPIC (<span class=\"match\">semaglutide</span>). OZEMPIC 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 USPTO received a patent term restoration application for OZEMPIC (U.S. Patent No. 8,129,343) from Novo Nordisk"},{"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":"2017-21176","html_url":"https://www.federalregister.gov/documents/2017/10/03/2017-21176/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting-establishment-of-a-public","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21176.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-21176.pdf?1506948343","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":"meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.\n \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n Agenda: \n The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for <span class=\"match\">semaglutide</span> injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.\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"}]}