EMA Stands By Suspension Of Ranitidine In EU After Re-Examination
Suspension of heartburn remedy ranitidine looming in the EU as the European Medicines Agency stands by its original decision.
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EMA has set out four conditions which marketing authorization holders must meet before the suspension of ranitidine across Europe can be lifted.
Concerns over the presence of a probable human carcinogen will likely see marketing of all ranitidine-containing drugs suspended across the European Union.
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.