周四,美国一名地区法官驳回了一家复合药行业组织提出的一项禁令申请,该申请旨在继续生产诺和诺德(NVO.US)减肥药Ozempic和Wegovy低价仿制版本,即便此前美国食品药品监督管理局(FDA)已声明,这类GLP-1受体激动剂药物不再处于短缺状态。
今年二月,美国食品药品监督管理局(FDA)宣布结束对司美格鲁肽注射剂长达数年的短缺认定后,以复合药行业协会Outsourcing Facilities Association为首的原告方提起了诉讼。
这一监管决定对远程医疗公司Hims & Hers(HIMS.US)股价造成冲击。该公司去年推出的复合版司美格鲁肽售价大幅低于品牌版本。
据媒体援引法庭记录报道,美国得克萨斯州地区法官Mark Pittman驳回了原告方关于初步禁令的动议。
根据法院裁决,在FDA分别给予的宽限期(至4月22日和5月22日)结束后,复合药房及外包设施将不得继续生产司美格鲁肽仿制药。
据悉,今年3月,Pittman法官曾以相同理由,驳回了Outsourcing Facilities Association就FDA终止礼来(LLY.US)减肥药Zepbound短缺认定提起的类似动议。
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