Drugs

FDA Releases New Ranitidine Contamination Test

FDA says it is releasing a second liquid chromatography-mass spectrometry method for use in detecting and quantifying NDMA in ranitidine. The agency also announced two ranitidine recalls.

An agency statement says FDA is using the new method to test potential NDMA-containing ranitidine samples. The method uses a more widely available technology than the first method FDA released, the statement says.

Recalls of ranitidine were announced for prescription and over-the-counter tablets and capsules manufactured by Dr. Reddy’s and possibly labeled for retailers such as Walgreens, Walmart, CVS, Target, and Kroger, and for Sanofi due to possible NDMA contamination.

The agency statement says patients taking prescription ranitidine should talk to their healthcare professional about other treatment options, while those taking over-the-counter products, indicated for preventing and relieving heartburn associated with acid indigestion and sour stomach, could consider using other OTC products. Preliminary tests of OTC Pepcid. Tagamet, Nexium, Prevacid, and Prilosec found no NDMA in the samples, FDA says.

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