Novartis's Sandoz Halting Ranitidine Distribution
September 18 2019 - 1:12PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
Novartis (NYSE:NVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novartis (NYSE:NVS)
Historical Stock Chart
From Apr 2023 to Apr 2024