EMA's Decision On Ranitidine Remaining Available Could Come At End Of April
Following the US request for ranitidine drugs to be withdrawn from the market, the European Medicines Agency says it would decide the fate of the products in the EU after wrapping up its own inquiry.
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FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.