Drugs

Haloderm Marketing Unapproved New Drugs: FDA

FDA says its review of the Haloderm, Inc., Web site indicated the firm takes orders for products that are unapproved new drugs the company is marketing directly to consumers. A 10/6 Warning Letter says the company’s products “are concerning from a public health perspective because they are labeled to contain the ingredients bloodroot and zinc chloride. Both substances are known corrosive agents. The combination of bloodroot and zinc chloride results in a corrosive agent capable of indiscriminately damaging healthy and diseased tissue alike and forming eschar (sloughed dead tissue).”

The letter says the agency also has concerns about products marketed over-the-counter directly to consumers for the removal of moles. It says moles should be evaluated by a healthcare practitioner and that self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and even cancer progression.

FDA says it recognizes that the Haloderm products are labeled as homeopathic drugs and says that homeopathic drug products are subject to the same regulatory requirements as other drugs.

Haloderm was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, along with copies of related documentation and a schedule for completing the corrections.

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