FDA widens generic drug recall probe beyond heart meds

FDA扩大除心脏病外仿制药召回调查

2019-08-29 12:00:39 pharmamanufacturing

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The FDA is reportedly expanding its investigation related into impurities found in a class of blood pressure medications. Last year, the agency triggered a recall for several angiotensin II receptor blockers (ARBs) such as valsartan, due to the presence of a chemical contaminant that has been linked to cancer. Now the FDA says it is looking into other classes of drugs that have a similar manufacturing process for potential impurities. The agency did not specify which class of drugs specifically it’s testing.  The initial recall of blood pressure medications happened after the cancer-causing toxins were found in APIs used by Zhejiang Huahai Pharmaceuticals Co. in China. Since then, the recall has impacted a number of major companies including Teva and Novartis’ Sandoz.
据报道,美国食品和药物管理局正在扩大对一类血压药物中发现的杂质的调查。 去年,该机构召回了一些血管紧张素II受体阻滞剂(ARB),如缬沙坦,因为存在与癌症有关的化学污染物。现在,FDA说他们正在研究其他种类的药物,这些药物具有类似的潜在杂质制造工艺。该机构没有具体说明正在测试哪一类药物。 在中国浙江华海药业有限公司使用的原料药中发现致癌毒素后,首次召回了血压药物。从那时起,召回事件已经影响了包括Teva和Novartis'Sandoz在内的许多大公司。

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