Oct 2 (Reuters) - The U.S. Food and Drug Administration and international health authorities are investigating the safety of Zantac heartburn medicine, also sold generically as ranitidine, after finding a probable cancer-causing impurity here in the drug.
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:
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.
Zantac becomes the world’s best selling drug and one of the first-ever drugs to top $1 billion in annual sales.
Glaxo’s U.S. patent for ranitidine expires and competitors launch generic alternatives to the drug.
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.
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.
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. (Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; editing by Grant McCool)