Drugs

Purell Hand Sanitizers Unapproved New Drugs: FDA

FDA says it has determined that Purell Healthcare Advanced Hand Sanitizer products marketed by Gojo Industries, Cuyahoga Falls, OH, are intended for use as consumer and healthcare antiseptics and, as formulated and labeled, are unapproved new drugs. A 1/17 Warning Letter lists some of the company claims for the products that indicate they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.

“FDA is currently unaware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus,” the letter says.

The letter says the Purell products are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. And it says that while FDA currently is not objecting to the marketing of products that meet the proposed formulation and labeling conditions described in a tentative final monograph, the Purell products do not comply with the relevant tentative final monograph.

Gojo was told to promptly correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, as well as documentation of each step and a timetable for completion.

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