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Vanda Pharmaceuticals Announced Notice of Opportunity for an FDA Hearing on Supplemental New Drug Application for HETLIOZ to Treat Jet Lag Disorder
Vanda Pharmaceuticals Announced Notice of Opportunity for an FDA Hearing on Supplemental New Drug Application for HETLIOZ to Treat Jet Lag Disorder
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) to treat jet lag disorder. On August 19, 2019, Vanda reported that it had received a Complete Response Letter from the FDA for Vanda's sNDA for HETLIOZ for the treatment of jet lag disorder. On July 1, 2022, Vanda submitted a request for an opportunity for a hearing under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) on the question of whether the sNDA is approvable. On August 26, 2022, Vanda received a notice of opportunity for hearing from the FDA. The FDA has indicated that it will publish the notice in a forthcoming issue of the Federal Register, but has not indicated when. Vanda is making the notice available to the public here. Vanda has provided the FDA with four clinical studies that Vanda believes are adequate and well controlled and provide substantial evidence of efficacy for HETLIOZ in the treatment of jet lag disorder. Vanda does not agree with the FDA's characterization of these studies and the conclusions reached by the FDA with respect to the sufficiency of its evidence to meet the standard of substantial evidence of efficacy. Vanda welcomes further administrative proceedings and remains committed to obtaining FDA marketing approval for HETLIOZ for the treatment of jet lag disorder in order to address this significant unmet medical need.
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) to treat jet lag disorder. On August 19, 2019, Vanda reported that it had received a Complete Response Letter from the FDA for Vanda's sNDA for HETLIOZ for the treatment of jet lag disorder. On July 1, 2022, Vanda submitted a request for an opportunity for a hearing under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) on the question of whether the sNDA is approvable. On August 26, 2022, Vanda received a notice of opportunity for hearing from the FDA. The FDA has indicated that it will publish the notice in a forthcoming issue of the Federal Register, but has not indicated when. Vanda is making the notice available to the public here. Vanda has provided the FDA with four clinical studies that Vanda believes are adequate and well controlled and provide substantial evidence of efficacy for HETLIOZ in the treatment of jet lag disorder. Vanda does not agree with the FDA's characterization of these studies and the conclusions reached by the FDA with respect to the sufficiency of its evidence to meet the standard of substantial evidence of efficacy. Vanda welcomes further administrative proceedings and remains committed to obtaining FDA marketing approval for HETLIOZ for the treatment of jet lag disorder in order to address this significant unmet medical need.
亚洲网加利福尼亚州圣克拉拉8月23日电万达制药公司(Vanda)(纳斯达克市场代码:VNDA)今天宣布,FDA将举行听证会,讨论万达针对Hetlioz(Tasimelteon)治疗时差障碍的补充新药申请(SNDA)。2019年8月19日,万达报告称,已收到FDA关于万达针对Hetlioz治疗时差障碍的sNDA的完整回复信。2022年7月1日,中达根据《联邦食品、药品和化妆品法》(《美国联邦法典》第21编第355(D)节)第505(D)节提交了关于sNDA是否可批准的听证机会的请求。2022年8月26日,万达收到FDA的听证机会通知。FDA已经表示,它将在即将出版的《联邦纪事报》上发表这一通知,但尚未指明何时发布。万达正在向这里的公众公布这份通知。Vanda向FDA提供了四项临床研究,Vanda认为这些研究充分且控制良好,并为Hetlioz治疗时差障碍的疗效提供了实质性证据。Vanda不同意FDA对这些研究的描述,以及FDA就其证据是否足以达到疗效的实质性证据标准所得出的结论。万达欢迎进一步的行政程序,并继续致力于获得FDA对Hetlioz治疗时差障碍的营销批准,以满足这一重大的未得到满足的医疗需求。
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在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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