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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Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
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.
Ranitidine Cancer Risk Found Only By Litigation Plaintiffs’ ‘Unreliable’ Research, Judge Rules
Plaintiffs in Multi-District Litigation didn’t provide scientific evidence of OTC heartburn drug Zantac increasing risk of cancer. Federal judge says plaintiffs' research showed “a lack of substantiation for analytical leaps” in alleging dangerously high levels of NDMA in ranitidine drugs.
Sanofi Eyes Using Zantac 360 Most-Recommended Ad Claim With Disclaimer Highlighting Ingredient
Industry self-regulation group’s appeals board agrees with investigative division’s finding Sanofi didn’t support Zantac 360 “#1 doctor recommended” ad claims. Board declines to consider whether “#1 doctor recommended H2 active ingredient” with “based on generic acid reducer recommendations” disclaimer is supported.