Hello all,
Does anyone know if any health authority (besides the U.S. FDA) has published a limit for N-Nitroso-Vonoprazan? I’ve already checked guidelines from EMA, Health Canada, TGA, HSA, COFEPRIS, ANVISA, Swissmedic, and WHO.
Thank you in advance
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Most health authorities only publish NDSRI RAILs linked to APIs with marketing authorisation on their territory. I believe Phathom Pharmaceuticals has not yet received marketing approval for Canada and EU (for which they hold the commercial rights). I don’t know if Phathom Pharmaceuticals or your company Takeda has the commercial rights for Australia, but I’m not aware about marketing approval for Australia as well.
Recently Phathom Pharmaceuticals said their current strategic focus remains US.
Previous discussions on NVP AI:
Phathom Pharmaceuticals reported nitrosamine impurity in their vonoprazan-based products - Nitrosamines in the News - Nitrosamines Exchange
N-nitroso Vonoprazan AI 96 ng/day- FDA - Limits of Nitrosamines - Nitrosamines Exchange
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Oi Isabella,
O FDA publicou o limite para a N-nitroso-vonoprazan. Ela está no final da Tabela 2
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limits
Espero ter ajudado.