After 2018 saw numerous sartan drugs recalled for possible carcinogenic impurities, in 2019, the industry kept an eye on the regulatory issues that followed and the breakthroughs that have mitigated some of the risks.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
US FDA announces that a new generic for valsartan will reach the market, after prioritising the review of the product to alleviate shortages resulting from recalled products.
Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.
Novartis exercises its option to license Ionis’ RNA-targeting cardiovascular drug, adding to its cardiovascular treatment portfolio, as Entresto reaches the three-year mark on its patent.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
FDA provided an update on its valsartan contamination investigation and suggested it had discovered two possible causes of the carcinogenic impurities.
The European Medicines Agency has unearthed a ‘sartan’ medication, in losartan, that contains low levels of the carcinogenic substance, N-nitrosodiethylamine.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
