Drugs

FDA Releases ‘Purell’ Warning Letter

FDA has released a 1/17 Warning Letter sent to Gojo Industries, Cuyahoga Falls, OH, asserting that because the firm’s Purell Healthcare Advanced Hand Sanitizer product line is intended for use as consumer and healthcare antiseptics it is considered an unapproved new drug. The letter contains examples of claims from the firm’s product Web sites that indicate the products are intended to reduce or prevent disease from the Ebola virus, norovirus, and influenza.

“FDA is currently not aware 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 products also are considered to be new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling, FDA says. Further, the letter says, although the company suggests its products are marketed under over-the-counter drug review, they do not comply with the relevant tentative final monograph.

Gojo was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of actions taken, documentation of each action, and a schedule for completion of the actions.

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