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Novartis's Sandoz Halting Ranitidine Distribution

By Michael Dabaie

 

Novartis AG's (NVS) Sandoz division halted distribution of generics of Zantac, or ranitidine, as a precaution.

The U.S. Food and Drug Administration last week said it has learned of a probable human carcinogen, called NDMA, found at low levels in some versions of the heartburn drug.

"A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA," Novartis said in a statement. "Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant Health Authorities as required."

Health Canada said Tuesday that "at Health Canada's request, companies marketing ranitidine products in Canada have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels."

The European Medicines Agency said last week at the request of the European Commission, it is reviewing ranitidine medicines. "EMA is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA," the agency said.

Novartis ADRs were nearly flat in midday trading, recently down 0.06% at $86.48.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

September 18, 2019 12:57 ET (16:57 GMT)

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