Drugs

Canadian Companies Sentenced in Unapproved Drugs Scheme

A federal court has sentenced Kristjan Thorkelson (Manitoba, Canada) and several associated Canadian companies to forfeit $29 million in illegal proceeds and to pay a $5 million fine for shipping unapproved drugs to U.S. healthcare providers. “In 2010, it came to the attention of the FDA that Canada Drugs was shipping to health care providers in the United States prescription drugs that were unapproved in the United States, labeled with foreign languages, and that lacked adequate instructions for use,” a government release says. “In two instances, Canada Drugs, through its subsidiary River East Supplies, distributed counterfeit cancer drugs Avastin and Altuzan (the Turkish version of the drug) in the United States. Testing of vials of the drugs recovered from these shipments revealed that both contained no active ingredient.”

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