Impurity detected in single-agent entacapones
By Kang, Shin-Kook | translator Kim, Jung-Ju
24.04.18 12:05:38
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Company reports the detection of nitrosamine impurities in entacapone-containing drugs
t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease.
According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based on the submitted test and inspection results, following a company report that nitrosamine impurities (NDEA, N-nitrosodiethylamine) were detected in its entacapone-containing drugs.
In other words, if there is a medical need for the drug or there is a concern about supply interruptions (shortage), the government plans to apply a temporary permissib
Kang, Shin-Kook(ksk@dailypharm.com)
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