Sanofi Returning Zantac OTC Heartburn Remedy Brand To US Market Formulated With Famotidine
Consumer Health Gets Little Mention In Q1 Results After Sales Dip 7%
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.
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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.
Firm opts for recall "as a precautionary measure due to inconsistencies in preliminary test results of the active ingredient used in the US and Canadian products." Other firms marketing ranitidine in US have started recalls due to concerns about NDMA since potential problem became known in September.
Brand’s management says its packaging redesign “was inspired by the Nature Made heritage and Nurish mission that healthy living should be joyful.” It partnered with branding consultancy Spicefire to develop brand and packaging to evoke Pharmavite’s 50 years of providing supplements.