FDA核准第一個Losartan學名藥物用於治療高血壓

作者：Yael Waknine  
出處：WebMD醫學新聞

　　April 9, 2010 — 美國食品藥物管理局（FDA）核准第一個Losartan potassium錠劑，單獨使用或與hydrochlorothiazide併用的學名藥物（Cozaar與Hyzaar，默克藥廠），用於治療高血壓。
　　
　　獲得核准的Losartan錠劑規格有25-mg、50-mg與100-mg三種劑量；Losartan/hydrochlorothiazide複方錠劑則有50 mg/12.5 mg、100 mg/12.5 mg、與100 mg/25 mg三種規格（Teva藥廠，美國）。
　　
　　100-mg/12.5-mg的Losartan/hydrochlorothiazide劑型將由數個不同公司製造，包括Mylan藥廠、Roxane實驗室有限公司、以及Torrent藥廠有限公司。
　　
　　根據FDA官員表示，Losartan學名藥物將和它們的對應產品有一樣的安全性考量，包括不得於懷孕第二期或第三期使用的黑框警示。
　　
　　  


FDA Approves First Generic Formulations of Losartan for Hypertension

By Yael Waknine
Medscape Medical News

April 9, 2010 — The US Food and Drug Administration (FDA) has approved the first generic formulations of losartan potassium tablets, alone and in combination with hydrochlorothiazide (Cozaar and Hyzaar, Merck Company, Inc), for the treatment of hypertension.

Losartan tablets have been approved in 25-mg, 50-mg, and 100-mg doses; losartan/hydrocholorothiazide combination tablets will be available in strength of 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg (Teva Pharmaceuticals, USA).

The 100 mg/12.5 mg losartan/hydrochlorothiazide formulation will also be manufactured by several other companies, including Mylan Pharmaceuticals Inc, Roxane Laboratories Inc, and Torrent Pharmaceuticals Ltd.

According to FDA officials, the generic losartan products will carry the same safety concerns as their brand counterparts, including a boxed warning against usage during the second and third trimesters of pregnancy.