Drugs

FDA Approves Pfizer’s Abuse Deterrent Pain Drug

FDA has approved a Pfizer NDA for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, indicated for treating pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The approval covers the drug’s properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. “However, abuse of Troxyca ER by these routes is still possible,” the company says.

The capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist. “When taken as directed, the naltrexone is intended to remain sequestered and patients receive oxycodone in an extended-release manner,” Pfizer says. “Studies demonstrated that when the pellets are crushed the sequestered naltrexone is released and is available to counteract the effects of oxycodone.”

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