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Stop selling illegal narcotics: the US FDA sends a warning to drug companies

机译:停止销售非法麻醉品:美国FDA向制药公司发出警告

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摘要

The US FDA has warned nine companies to end the production of 14 narcotic painkillers that have not received regulatory approval. An estimated 2% of prescription drugs reach the market without approval, and most of these are generic variations of other drugs already being marketed.Each of the targeted drugs highlighted in the recent warning letters are morphine relatives. They are either immediate-release, fast-acting morphine, hydro-morphone or oxycodone pills, or highly concentrated liquid forms of morphine. The drugs under scrutiny either did not go through the approval process or were introduced before the US FDA had ruled on the applications to approve them.
机译:美国食品和药物管理局警告九家公司停止生产尚未获得监管部门批准的14种麻醉性止痛药。估计有2%的处方药未经批准就进入了市场,其中大多数是已经上市的其他药物的通用变体。最近警告信中突出显示的每种靶向药物都是吗啡亲戚。它们可以是速释,速效吗啡,氢吗啡酮或羟考酮药丸,也可以是高浓度吗啡液体制剂。接受审查的药物要么没有经过批准程序,要么在美国FDA决定批准其申请之前就已引入。

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    《Therapy》 |2009年第5期|共1页
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  • 正文语种 eng
  • 中图分类 治疗学;
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