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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Drug companies deadlines are nearing to meet regulatory requirements relating to nitrosamine impurities found in their products as guidelines are being revised or re-published.
GSK Agreed To Settle California Zantac Litigation After Judge Cleared Plaintiff's Experts To Testify
State court judge would've allowed testimony from 13 of 14 witnesses plaintiff proposed as experts for trial scheduled to start in late July. Plaintiff’s attorneys said decision on experts “signals significant litigation on the horizon for GSK.”
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.