US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
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.
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Revision to FDA's September 2020 guidance on assessing nitrosamine impurity risks associated with all chemically synthesized APIs and all approved drug products that contain those APIs doesn’t satisfy industry stakeholders.
JAMA study found under simulated gastric conditions a standard tablet of ranitidine yielded NDMA to three orders of magnitude beyond established exposure limits. Rapid formation of NDMA appears to continue for extended periods in gastric conditions, say researchers from Memorial Sloan Kettering and Valisure.
EMA has set out four conditions which marketing authorization holders must meet before the suspension of ranitidine across Europe can be lifted.