FDA不反对含NMBA低于9.82ppm的氯沙坦保持销售

翻译：JULIA   来源：Julia法规翻译 FDA not objecting to losartan with NMBA below 9.82 ppm remaining on the marketFDA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 ………………………………