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First Zantac trial slated for February 2023

By Brian Buntz | June 28, 2022

Zantac

[Image courtesy of Wikimedia Commons]

The California State Court Judge overseeing litigation related to Zantac (ranitidine) issued a pretrial order scheduling the first of four bellwether trials for Feb. 13, 2023, in Oakland.

Honorable Judge Evelio M. Grillo for the California Superior Court of Alameda County will preside over the litigation. Before the cases head to trial, Judge Grillo will verify that the experts tapped by the plaintiffs and defendants used sound logic in arriving at their scientific conclusions. Then, if plaintiffs’ experts persuade the judge, the first bellwether trial will proceed.

The heartburn medication Zantac, launched in 1983, was the best-selling drug in history in 1996. First developed by Glaxo Holdings Ltd, ranitidine remained popular until FDA yanked it from the market in 2020. The agency noted that the drug frequently contained the potentially cancer-causing contaminant N-nitrosodimethylamine (NDMA).

The level of NDMA can increase with time and when the drug is stored at elevated temperatures. NDMA belongs to a large class of N-nitrosamines. NDMA is also found in low levels in some foods and drinking water.

Before the FDA pulled ranitidine from the market, the drug was available as an OTC and prescription medicine. In 2019, physicians prescribed ranitidine almost 14 million times.

Several drug companies have manufactured ranitidine internationally, including Boehringer Ingelheim, Sanofi, Roche, Pfizer and GlaxoSmithKline (GSK).

The U.S. patents for the drug expired in 1993.

Sanofi now holds the branding rights for Zantac. The company has substituted ranitidine for famotidine, another histamine H2 receptor antagonist.

The second bellwether trial is currently scheduled for May 1, 2023. The third is slated for Aug. 7 and the fourth for Oct. 23, 2023.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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