The Safety of AQUAFLOR (50% florfenicol; Type A Medicated Article) Administered in Feed to Marine Finfish Species

%20Safety%20of%20AQUAFLOR%20(50%%20氟苯尼考；%20Type%20A%20Medicated%20Article)%20Administered%20in%20Feed%20to%20Marine%20Finfish%20Species

• 批准号: 10562359
• 负责人: Rodman G Getchell
• 金额: $ 20.47万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10562359
• 关键词: Safety; AQUAFLOR; 50; florfenicol; Type

Project Summary / Abstract Generation and dissemination of data for safe and effective therapeutic applications for minor use in major species or for use in minor species is a priority of the FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS). This project addresses the need to increase the availability of therapeutics to sectors of the aquaculture industry not covered by the original approval. The lack of approved drugs for marine finfish producers is threatening the growth and long-term viability of these collective industries and the security of our food supply. Although some new aquaculture drugs have been added to the collective finfish “medicine chest” in the past 10-15 years, the total number of FDA-approved drugs for aquatic animals is still very limited. Researchers within the Cornell University Aquatic Animal Health Program and USFWS Aquatic Animal Drug Approval Partnership (AADAP) program are proposing to continue a collaboration to conduct studies to increase the number of safe and effective drugs that can be used to benefit the U.S. aquaculture community. Trials will be conducted with Florfenicol (AQUAFLOR®), which is used to treat specified diseases of fish. Cornell University’s Aquatic Animal Health Program brings a long history of conducting research on fish therapeutants and was funded by NIFA during the last two years. This grant application proposes tasks that will be completed in partnership with the team of researchers, pathologists, statisticians, and quality assurance personnel at both the Cornell University College of Veterinary Medicine and AADAP. This study will evaluate the safety of AQUAFLOR® to saltwater-reared marine finfish administered in feed to marine finfish species at 0× (0 mg), 1× (15 mg), 3× (45 mg), or 5× (75 mg) the maximum proposed therapeutic dose of 15 mg florfenicol/kg fish/day for 20 consecutive days (2× the proposed therapeutic treatment duration of 10 consecutive days). The target animal safety study of AQUAFLOR® will be conducted with juvenile marine finfish species. The results of these safety studies, if accepted by FDA/CVM, will be used to complete the TAS technical section data requirements for marine finfish and support a New Animal Drug Application to FDA/CVM to approve the use of AQUAFLOR® for the control of mortality in seawater-reared finfish due to yellowmouth associated with Tenacibaculum maritimum.

项目总结/摘要 生成和传播安全和有效的治疗应用数据，供少数人在主要疾病中使用 FDA/CVM的次要用途和次要种属动物办公室优先考虑 药物开发（OMUMS）。该项目解决了增加治疗药物的可用性的需要， 原批准范围以外的水产养殖业。缺乏批准的海洋药物 鱼类生产者正在威胁这些集体产业的增长和长期生存能力， 我们的食物供应。虽然一些新的水产养殖药物已被添加到集体鳍鱼“药 在过去的10-15年里，FDA批准的用于水生动物的药物总数仍然非常有限。 康奈尔大学水生动物健康项目和USFWS水生动物药物的研究人员 批准伙伴关系（AADAP）计划提议继续合作进行研究，以增加 可用于造福美国水产养殖社区的安全有效药物的数量。试验将 氟苯尼考（AQUAFLOR®），用于治疗特定的鱼类疾病。康奈尔 大学的水生动物健康计划带来了对鱼类治疗剂进行研究的悠久历史 在过去的两年里由NIFA资助。这份拨款申请提出了将完成的任务 与研究人员、病理学家、统计学家和质量保证人员合作， 康奈尔大学兽医学院和AADAP。本研究将评估以下药物的安全性： AQUAFLOR®对海水养殖的海洋有鳍鱼类的影响，以0×（0 mg）、1× (15 mg）、3×（45 mg）或5×（75 mg）最大拟定治疗剂量15 mg氟苯尼考/kg鱼/天， 连续20天（2×拟定治疗持续时间，连续10天）。靶动物 AQUAFLOR®的安全性研究将在幼年海洋鳍鱼物种中进行。这些安全性的结果 如果FDA/CVM接受，研究将用于完成TAS技术部分的数据要求， 并支持向FDA/CVM提交新兽药申请，以批准AQUAFLOR®用于 与海洋韧杆菌相关的黄口病引起的海水养殖有鳍鱼死亡率的控制。