Januvia®: [Diabetes Medicines, Generally] In Short Supply. Thus Merck Has An Okay From FDA To Remediate Tiny Nitrosamine Contaminant Levels By Year End 2023.

First off, let's define the itty-bitty scale here: this would amount to about 0.037 of a milligram per LITER of fluid, or powder. Thus this is effectively -- and merely -- a drop, in an ocean, here. [Your tiny aspirin pill contains about 250 ml of active ingredients in each small powder pill tablet -- so, over 50,000 times more than this nitrosamine level.]

But that level of contaminant -- at a top end of about 37 nanograms/ml -- slightly exceeds the GMP specs that FDA originally approved for Merck's Januvia^® and Janumet^®, as long term sales leaders in the diabetes space.

To be clear, though, in concentrations of many thousands of times higher than this. . . in animal study models, some excess cancer rates were observed. [Clearly then, the risk of "going without" one's diabetes medications. . . greatly exceeds any risk from taking the drug.] But as I say, the whole space is undergoing a supply shortage, with similar contaminants turning up even in the generic versions at Lupin and Glenmark, out of India.

So, FDA has wisely given Merck a provisional green light (until year end) to continue shipping while remediating it. The company now knows the source of the contaminant, and while it will not disclose whether it is due to problems with an API supplier (possibly in India or China), or residing much closer to Merck's own captive facilities -- it says it will have it all fixed up, by January 2024.

Here is the bit, from FiercePharma, earlier today:

. . .In a report to the FDA, Merck says it has figured out how its blockbuster type 2 diabetes drugs have become contaminated with nitrosamine. And the company has told the regulator that it can fix the issue by the end of this year, a source told Bloomberg. . . .

Now you know -- off to the flannel sheets. . . chanting my name. . . sweet and low, but chanting, just the same. G'night.

नमस्ते