California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target
Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.
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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 Returning Zantac OTC Heartburn Remedy Brand To US Market Formulated With Famotidine
Along with its Q1 results including a 7.3% drop in consumer health sales to €1.11bn ($1.35bn), Sanofi announces 10-mg famotidine tablets branded Zantac 360° will be available in the US in June.