Nitrosamine concerns in Priftin (Rifapentine)

News

9 July, 2020 - 14:00 (CEST)

Alerts

WHO Prequalification Unit - Medicines Assessment Team (PQT/MED), has been in contact with Sanofi regarding the presence of a nitrosamine impurity in their tuberculosis treatment - Priftin (Rifapentine). PQT/MED, prequalified this medicine as TB336, based on SRA approval. In this instance, prequalification was based upon the registration of this product with the USFDA.

Sanofi has temporarily ceased release of batches of Priftin whilst remedial actions are considered. WHO’s previous advise regarding products at risk of nitrosamine contamination remains relevant to this situation and can be located at this webpage:

Information Note Nitrosamine impurities

Sanofi continues to communicate with the USFDA on this matter to find a suitable way forward that would allow resumption of batch release. Sanofi is providing regular updates to PQT/MED on this matter.

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