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FDA Approves Cymbalta For New Indication

机译:FDA批准Cymbalta用于新适应症

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Eli Lilly has received FDA approval to expand Cymbalta's generalized anxiety disorder (GAD) indication for maintenance treatment of the condition in adults.rnCymbalta (duloxetine HC1) is approved for acute treatment of the disorder in adults, and also for major depressive disorder, management of diabetic peripheral neuropathic pain and fibromyal-gia, the company says in a statement last week.rnApproval for the new indication was based on a double-blind, placebo-controlled trial of 429 patients who initially had responded to maintenance treatment with Cymbalta for GAD during a 26-week open-label phase of the trial.
机译:礼来制药(Eli Lilly)已获得FDA的批准,以扩大Cymbalta的广泛性焦虑症(GAD)适应症,以维持成人的病情.rnCymbalta(度洛西汀HC1)已获批准用于成人的急性治疗,以及重大抑郁症的管理该公司上周在一份声明中说,糖尿病周围神经性疼痛和纤维肌痛。rn新批准适应症的批准基于对429例患者的双盲安慰剂对照试验,该试验最初对Cymbalta维持治疗期间的GAD有反应为期26周的开放标签试验阶段。

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