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US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

 
• By Malcolm Spicer

Novartis, which licensed OTC Zantac for US marketing to Sanofi, stops distribution of the histamine-2 blocker ranitidine to presence of NDMA, a probable carcinogen. Decision doesn’t affect US sales of OTC Zantac in US, where FDA says NDMA found in ingredient is at low levels.

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Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while the firm conducts its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient ranitidine are above safe levels.

Novartis AG, which licenses OTC Zantac formulations (75- and 150-mg ranitidine) for US marketing to Sanofi while continuing to market the brand and to supply ranitidine for other firms in other countries, has said it stopped distribution of the

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