【2 月 8 日,艾伯维称美国食品和药物管理局批准其治疗复杂性腹腔内感染的药物】艾伯维和辉瑞公司共同开发的药物 Emblaveo 获准与抗生素药物联 ...
智通财经APP获悉,艾伯维(ABBV.US)公司宣布,美国FDA已批准该公司与辉瑞(PFE.US)联合开发的Emblaveo(aztreonam和avibactam)上市,与甲硝唑联合使用,治疗18岁及以上复杂性腹腔内感染(cIAI)患者,包括由多种耐药性革兰氏阴性菌导致的感染。这些患者缺乏其它替代治疗方案。
Approval of this indication is based on limited clinical safety and efficacy data for Emblaveo. In REVISIT, study participants with cIAI (n=312) were randomly assigned 2:1 to receive aztreonam ...
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited ...
Ten months after Pfizer scored approval in Europe for Emblaveo (aztreonam and avibactam) to treat complicated intra-abdominal infections (cIAIs), AbbVie has done the same in the U.S., winning an ...
AbbVie said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections ...
AbbVie (NYSE:ABBV) said it has received FDA approval for the intravenous antibiotic treatment Emblaveo, which was co-developed with Pfizer (NYSE:PFE). The FDA approved Emblaveo, a combination of ...
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