Unofficial/official surrogates for read-across

[Yosukemino]

Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks

Pfizer is restricting the shipments of and eventually plans to recall its antidepressant Amoxan (amoxapine) in Japan after detecting cancer-causing impurities. When I get further information, I will post it. [image] Amoxapine

N-Nitrosobupropion

Hi !!! It has been came to the notice recently that N-nitroso bupropion is one of the NDSRI in Bupropion formulations whose limit has not been defined by any regulatory agency. What will be the AI of N-nitroso bupropion ???

Phathom Pharmaceuticals reported that it has detected trace levels of a nitrosamine impurity in their vonoprazan-based products (may be NDSRI, nitroso-Vonoprazan ? ) that is not described within the FDA Nitrosamine guidance document

Phathom Pharmaceuticals reported that it detected trace levels of a nitrosamine impurity (may be NDSRI, nitroso-Vonoprazan ?? ) that is not described within the FDA guidance document entitled “Control of Nitrosamine Impurities in Human Drugs – Guidance for Industry.” The Company is working with the FDA and plans to obtain approval of and implement an additional test method, specification, including a proposed acceptable intake limit, and additional controls to address this impurity prior to rele…