翻译：JULIA   来源：Julia法规翻译 

FDA not objecting to losartan with NMBA below 9.82 ppm remaining on the market

FDA不反对含NMBA低于9.82ppm的氯沙坦保持销售

Update [3/20/2019] To ensure patient access to losartan, FDA will not object to certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyricacid (NMBA) above the interim acceptable intake limit of 0.96 parts permillion (ppm) and below 9.82 ppm until the impurity can be eliminated. The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.

更新【20190320】为确保患者可获得氯沙坦，FDA不会反对某些生产商暂时销售含NMBA高于临时可接受摄入限度0.96ppm但低于9.82ppm的氯沙坦，直到杂质可以清除。FDA预期在约6个月时间内会有多个公司可以生产不含亚硝胺杂质的氯沙坦补充美国市场。

Agency scientists evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and determined that it presents no meaningful difference in cancer risk over a six-month time period when compared to a lifetime of exposure to NMBA at 0.96 ppm. Distributing losartan containing NMBA up to 9.82 ppm, will help maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients.

FDA科学家们评估了暴露于9.82ppm水平的NMBA的风险，认为相比于终生暴露于0.96ppm的NMBA而言，6个月时长暴露于9.82ppm不会在患癌风险方面引起显著差异。销售含NMBA低于9.82ppm的氯沙坦将有助于在公司不含亚硝胺的氯沙坦生产工艺获得批准之前维持足够的氯沙坦供应给患者。

FDA reminds patients taking recalled losartan to continue taking their current medicine until their pharmacist provides areplacement or their doctor prescribes a different medication that treats the same condition. Untreated hypertension (high blood pressure) leads to anincrease in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death. Untreated diabetic nephropathy(kidney disease) leads to worsening renal (kidney) disease.

FDA提醒正在服用被召回氯沙坦的患者继续服用其目前所用药物，直至其药师提供替代药品，或其医生开具不同药物处方治疗相同病症。高血压不进行治疗会导致心脏病发作风险升高。心力衰竭不进行治疗会导致住院和死亡风险升高。糖尿病肾病不进行治疗会导致肾病恶化。

Manufacturers should contact FDA’s Drug Shortages Staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. FDA will determine, on a case-by-case basis, whether lots containing NMBA greater than 0.96 ppm should be released for distribution.

生产商在检出氯沙坦NMBA超出临时可接受摄入水平0.96ppm时，应联系FDA药品短缺处。FDA会各案决定超出0.96ppm NMBA的氯沙坦批次是否可以放行销售。

FDA continues to work with companies and international regulators to ensure products entering the U.S. market do not contain nitrosamine impurities.  

FDA将继续与公司和国际药监机构合作，确保进入美国市场的药品不含有亚硝胺杂质。