|
 Ranitidine is the newest drug in which presence of cancer causing
impurities have been found. Regulators have been recalling some
blood pressure and heart failure medicines since last year.
The following is a timeline on Zantac:
1983
Glaxo Holdings Ltd, now a part of GlaxoSmithKline PLC, receives its
first U.S. FDA approval for Zantac as a short-term treatment of a
common form of ulcers. The drug was already approved in 31 different
countries.
1988
Zantac becomes the world's best selling drug and one of the
first-ever drugs to top $1 billion in annual sales.
1997
Glaxo's U.S. patent for ranitidine expires and competitors launch
generic alternatives to the drug.
2004-2017
Pfizer receives FDA approval for an over-the-counter version of
Zantac in the U.S. The brand later moved in various transactions to
Johnson & Johnson, Boehringer Ingelheim Pharmaceuticals and Sanofi
SA, which currently sells Zantac in the U.S. Other companies also
launch generic over-the-counter competitors.
July 2018
European and American regulators recall blood pressure drug
valsartan made by China's Zhejiang Huahai Pharmaceuticals after
finding the cancer causing impurity N-nitrosodimethylamine (NDMA) in
samples of drugs containing ranitidine. The regulators have since
found the impurities in a wide number of the drugs in the same
class, called angiotensin II receptor blockers.
[to top of second column] |
Sept. 13, 2019
U.S. and European regulators say they are reviewing the safety of
ranitidine.
Sept. 18, 2019
Novartis AG's Sandoz Unit, which makes generic drugs, says it is
halting the distribution of its versions of Zantac in all markets,
while Canada requests drugmakers selling ranitidine to stop
distribution.
Sept. 28, 2019
Drugstore chain CVS Health Corp says it will stop selling Zantac and
its own generic ranitidine products. Walmart Inc, Walgreens Boots
Alliance Inc and Rite Aid Corp have also moved to remove the drugs
off their shelves.
Oct 2, 2019
FDA says it has found "unacceptable levels" of N-nitrosodimethylamine
(NDMA) in samples of drugs containing ranitidine in its testing.
Oct 8, 2019
GlaxoSmithKline, the original maker of the drug, recalls
prescription-only Zantac medicines in all its markets as a
precaution.
Oct 18, 2019
Sanofi recalls over-the-counter Zantac in the United States and
Canada, a day after the UK unit of Teva Pharmaceutical, the world's
largest generic drug maker, recalled some batches of ranitidine.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in New
York; editing by Grant McCool)
[© 2019 Thomson Reuters. All rights
reserved.] Copyright 2019 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |
