Drugs

Ranitidine Products May Return to Market: FDA

FDA says new analytical methods for detecting the carcinogen NDMA (N-nitrosodimethylamine) developed by CDER scientists have shown that actual levels of NDMA in ranitidine drug products were much lower than previously reported. In the “What is New in Regulatory Science” online summer issue, CDER says that to further address the cancer risk of ranitidine, a popular drug used to treat peptic ulcer and gastroenterological reflux disease that has been withdrawn from the market, the Center conducted a randomized clinical trial that concluded that ranitidine does not increase NDMA under physiological conditions.

“Based in part on this research, FDA may consider allowing ranitidine-containing products back on the market if they are proven to be stable, with low acceptable amounts of NDMA that do not increase during storage,” the newsletter says.

Other articles in the newsletter cover Covid-19 related updates, spotlight on CDER science, regulatory science impact stories, recent CDER staff science publications, upcoming events, and career opportunities.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome