Drugs

Apotex Recalls Some OTC Ranitidine Tablets

FDA says Apotex is recalling over-the-counter ranitidine tablets (75 mg and 150 mg), a generic form of Novartis’ Zantac labeled by Walgreens, Walmart, and Rite-Aid. An agency statement says the recalled tablets may contain low levels of a nitrosamine impurity, N-nitrosodiemthylamine (NDMA), which is classified as a probable human carcinogen.

“The recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines,” the statement says. “The agency also recently alerted patients and healthcare professionals of Sandoz’ voluntary recall of prescription ranitidine HCl capsules due to an NDMA impurity on 9/23.”

The notice says that not all ranitidine medicines marketed in the U.S. are being recalled and the agency is not recommending that individuals stop taking ranitidine medicines at this time.

FDA says it is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking the drug. And it has asked manufacturers to conduct laboratory testing to examine NDMA levels in ranitidine and to send drug samples to FDA for testing by its staff.

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

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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