To Avoid Supply Crunch, FDA Temporarily Allows Higher Impurity Levels In Merck's Diabetes Drug: Report

The FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck & Co Inc's MRK type 2 diabetes drug Januvia/Janumet (sitagliptin).
The agency said that to avoid a shortage and to help ensure patients have access to an adequate supply, the FDA said it would not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit of 37 ng per day and up to 246.7 ng per day.
Typically, if a drug contains levels of nitrosamines above the acceptable daily intake limit, the FDA recommends that the manufacturer conduct a recall.
The FDA also said it would determine on a case-by-case basis whether drugs should be released for distribution.
"Although there are no data available to evaluate the carcinogenic potential of NTTP directly, FDA used information available on closely related nitrosamine compounds to calculate lifetime exposure limits for NTTP," the agency said.
The drug collectively pulled in more than $10.5 billion for Merck in 2020 and 2021.
NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens based on laboratory tests, the agency said.
Price Action: MRK shares closed at $89.52 on Tuesday.
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