The FDA released a statement yesterday about Ritonavir and the potential contamination with NITMA.
October 28, 2024: Emerging Scientific and Technical Information on Ritonavir
I don’t remember the FDA releasing many statements like this before - certainly haven’t seen many personally. I find the last paragraph interesting…
Possible teaser that a Table 3 t-AI is coming? Risk/benefit and shortage minimization makes sense for this type of therapy.
Makes sense to reconfirm the step 2/3 deadline and not rush applicants in delivering testing, considering the complexity of method development and the effect this might have on interim batch release strategies especially for such important medicines.
Even if this nitrosamine was reported already, makes me think about the sitagliptin case in Europe, where on 8 July 2022 the EMA sent a letter with an obligation to provide NTTP testing by 1 September 2022 (before the step 2 - 26 September 2022 deadline) unless there was no active commercialisation. Such pressure might push to suboptimal methods or deprioritising testing products with actually a higher risk for the specific applicant portfolio.
I like the incentive to coordinate testing battery design with the agency prior to conducting studies.