Hi Friends,
Recently I am getting emails from clients on an issue related to the N-nitrosoduloxetine (ND) interim limit. Not sure if any of you faced anything similar. This is about the information in Table 3 on the website (CDER Nitrosamine Impurity Acceptable Intake Limits | FDA), where interim higher limits are provided. Recently the interim limit for ND was removed. I just realized that the FDA advised one of my clients, “The interim limit applies to the lots you manufacture before the date provided”. However, today a client came to me with this recommendation from the FDA, “The updated limit applies to all batches distributed from January 1, 2025, onward, regardless of the manufacturing date.” And the nitrosamine has been removed from Table 3. Now, my perception is that the information in the second advice is inline with the website information. But, I would have taken any of these recommendations at face value if they were not contradictory. Giving two different advice to two groups ion the same drug is really not the best scenario. Again, clarity and agreement within the FDA itself, better transparency in the written documents may be helpful. Let me know what your experience is. Again, these interim limits have nothing to do with safety, they are based on what the Agency is seeing in the products that are marketed. So, even with the current Table 3, dont draw any safety conclusions from these numbers.
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