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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