Drugs

Advisors Vote Against Remoxy Approval

Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the agency’s Drug Safety Advisory Committee have voted 14-3 to recommend that FDA not approve Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate.

The company says the drug has physical/chemical properties intended to deter abuse and still provide 12 hours of steady pain relief when properly prescribed by a doctor and used appropriately by patients.

At the joint committee meeting, Public Citizen Health Research Group co-founder Sidney Wolfe urged that Remoxy ER not be approved. Wolfe said that when the drug is chewed, it releases much more oxycodone than when swallowed. Thus, it actually would be abuse-enhancing, he said. He claimed that Remoxy’s modest effects in reducing intravenous and intranasal abuse would be undermined by the oral abuse.

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