Drugs

Sexual Enhancement Product Permanent Injunction

The New Jersey federal court has entered an order of permanent injunction against several firms and their executives charged with selling unapproved and misbranded drugs to U.S. consumers through more than 100 Web sites. According to an FDA statement, the defendants’ products claimed, without FDA approval or clinical studies demonstrating safety and effectiveness, that the products could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence, and prostatitis.

The statement says that FDA laboratory testing found that some of the products contained undisclosed sildenafil (Viagra). FDA says that using sildenafil, particularly when its presence is hidden from consumers, can pose serious health risks to patients with underlying medical issues such as heart disease and hypertension.

FDA issued a Warning Letter to the companies after the laboratory analysis. However, FDA says, the companies continued to refuse to comply with the law, leading the agency to seek the permanent injunction.

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