FDA批准首款仿制版Nexium

FDA 1月26日宣布批准首个Nexium（耐信）仿制药，即仿制版的埃索美拉唑镁缓释胶囊，用于治疗成人和1岁以上儿童的胃食管反流病。该仿制版Nexium由Teva旗下的Ivax制药公司生产，包括20mg和40mg两个剂量规格。

与Nexium一样，该款仿制药也被批准用于降低非甾体抗炎药引起的胃溃疡风险，杀灭幽门螺杆菌以降低十二指肠溃疡风险，以及治疗包括Zollinger-Ellison综合征在内的病理性高胃酸分泌症。患者服用该仿制版埃索美拉唑也需遵从药品标签 ，包括使用方法和潜在风险，如腹泻和骨折。

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The Food and Drug Administration approved the first generic formulation of esomeprazole magnesium delayed-release capsules, the agency announced Jan. 26.

The new generic formulation of Nexium is approved to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older, according to the FDA statement announcing the approval. Ivax Pharmaceuticals manufactures generic esomeprazole in 20-mg and 40-mg capsules. 

Like Nexium, generic esomeprazole is also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prescriptions for generic esomeprazole will be dispensed with a medication guide, which provides patients with information about esomeprazole’s uses and risks, including diarrhea and bone fractures. Nexium prescriptions also come with a medication guide. 

Ivax is a subsidiary of Teva Pharmaceuticals USA.

Copyright © 2015 Frontline Medical News, a Frontline Medical Communications, Inc. company. All rights reserved. This material may not be published, broadcast, copied or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications, Inc.

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