To avoid short­age of Mer­ck­'s di­a­betes drug, FDA al­lows high­er im­pu­ri­ty lev­els tem­porar­i­ly

The FDA said Tues­day that it re­cent­ly be­came aware of a ni­trosamine im­pu­ri­ty, Ni­troso-STG-19 or NTTP, in cer­tain sam­ples of Mer­ck’s type 2 di­a­betes drug Janu­via.

To avoid a short­age of the drug that pulled in more than $10.5 bil­lion for Mer­ck in 2020 and 2021, and to help en­sure pa­tients have ac­cess to an ad­e­quate sup­ply, the FDA said it will not ob­ject to the tem­po­rary dis­tri­b­u­tion of sitagliptin con­tain­ing the im­pu­ri­ty above the ac­cept­able in­take lim­it.

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