FDA alerts to a voluntary recall of varenicline - What do we know?

[Naiffer_Host]

I’m extremely curious to see who is dealing with this new API. It would be a great case study for Q(SAR) assessment since we have been talking extensively about the chemistry of Impurity @MichaelBurns @kpcross

To my knowledge, there are about 22 active regulatory filings for this API just in FDA (per public information)

Q&A Nitrosamine SAR working group (23 companies and universities)

#OpenQ&A This PPT was presented by Kevin P. Cross, PhD (Instem PLC) @kpcross and David J. Ponting, Ph.D. (Lhasa Limited) @David at QSAR 2021 and describes Lhasa and Instem’s collaborative efforts in the area of N -nitrosamine assessment, including the nitrosamine SAR working group - currently comprising of 23 companies and universities. QSAR2021 Cross Nitrosamines SAR FINAL.pdf (790.9 KB) [image] [image] [image]