Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs
Merck has identified what caused levels of the nitrosamine NTTP to appear in batches of its blockbuster diabetes drugs, the company confirmed on Wednesday.
An unnamed source told Bloomberg, which first reported the news, that NTTP contamination in certain batches of its sitagliptin diabetes products Januvia and Janumet occurred during storage and manufacturing processes.
The FDA said last August that it became aware of a nitrosamine impurity in certain samples of Merck’s type 2 diabetes drug Januvia. In order to avoid a shortage of the blockbuster drug, the agency temporarily allowed higher impurity levels than the acceptable intake limit.
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