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专业制药公司Heron Therapeutics旗下Zynrelef缓释溶液VAN预先批准补充申请获FDA批准

FDA approval of the Prior Approval Supplement Application for Zynrelef (bupivacaine + meloxicam extended release) Vial Access Needle ("VAN")- Heron Therapeutics

medthority 等信源发布 2024-09-26 11:00

可切换为仅中文


Heron Therapeutics, Inc. announced that the  FDA has approved the Company's Prior Approval Supplement Application for Zynrelef (bupivacaine and meloxicam) extended-release solution VAN (Vial Access Needle)

Heron Therapeutics,Inc.宣布,FDA已批准该公司对Zynrelef(布比卡因和美洛昔康)缓释溶液VAN(小瓶接入针)的事先批准补充申请

The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing Zynrelef 's withdrawal time down to between twenty and forty-five seconds. The user-friendly 'container-like' design of the VAN may enhance the safe use of Zynelef, increase adoption, and improve the preparation process..

该面包车将取代目前的通风瓶塞,有可能简化无菌准备,同时也将Zynrelef的撤离时间大大缩短到20到45秒。面包车人性化的“集装箱式”设计可以提高Zynelef的安全使用,增加采用率,并改进制备过程。。

'With this approval, we are providing healthcare providers with a new mechanism that directly addresses one of Zynrelef 's adoption hurdles and will help reduce preparation time for surgical staff,' said Bill Forbes, PharmD, Executive Vice President, Chief Development Officer at Heron. 'Reducing patients' pain during the first three days after surgery is critical for patient recovery and well-being following often painful procedures, and we anticipate the VAN will lead to increased Zynrelef  adoption, positively impacting patient recovery.'.

Heron执行副总裁兼首席开发官比尔·福布斯(BillForbes)说,通过这项批准,我们为医疗保健提供者提供了一种新机制,可以直接解决Zynrelef的收养障碍之一,并有助于减少手术人员的准备时间在手术后的前三天减少患者的疼痛对于患者的恢复和健康至关重要,我们预计VAN将导致Zynrelef的采用率增加,对患者的康复产生积极影响。”。

'The VAN approval, along with Zynrelef 's January label expansion, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief ('NOPAIN Act'), and the continued integration of our partnership with CrossLink Life Sciences, LLC ('CrossLink'), are all exciting milestones achieved during 2024 contributing to Zynrelef 's continued progress,' said Craig Collard, Chief Executive Officer at Heron.

Heron首席执行官克雷格·科拉德(CraigCollard)说,VAN的批准,以及Zynrelef在1月份的标签扩展,将其纳入拟议的2025年非阿片类止痛药政策(“NOPAIN法案”),以及我们与CrossLink Life Sciences,LLC(“CrossLink”)的合作伙伴关系的持续整合,都是2024年取得的令人兴奋的里程碑,有助于Zynrelef的持续进步。

'We remain optimistic about the potential transformative impact the VAN will have, following its expected launch in Q4 2024, providing healthcare professionals with an easier to use, versatile, and effective solution for managing postoperative pain across a wide range of surgical procedures.'.

“我们对该面包车在2024年第四季度预计推出后将产生的潜在变革性影响保持乐观,为医疗保健专业人员提供了一种更易于使用,通用且有效的解决方案,用于管理各种外科手术中的术后疼痛。”。

Condition: Pain:Post Surgical

情况:疼痛:手术后

Type: drug

类型:药物