Drugs

Declare Elysium Health Basis Supplement Adulterated: ChromaDex

ChromaDex, which says it is the only supplier of nicotinaminde riboside chloride (Niagen) that has been recognized by FDA as generally safe (GRAS), is asking the agency to investigate and take appropriate remedial action against Elysium Health over its Basis dietary supplement. The ChromaDex petition says that in the past, the company supplied Elysium with Niagen for use in Basis.

“However,” it says, “Elysium is now using a new supplier(s) for the ingredients in Basis, the identity of which is currently unknown. ChromaDex discovered … that Elysium’s new Basis product is contaminated with toluene, an industrial solvent used in such things as paint thinners, fingernail polish, lacquers, and adhesives. In addition, Elysium is now using a nicotinamide riboside chloride ingredient in its product for which no New Dietary Ingredient notification has been filed with FDA, and which does not have GRAS status. As such, Elysium’s Basis product should be found to be adulterated and FDA should take prompt remedial action to protect public health and safety.”

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