Drugs

Reject Intellipharmaceutics Oxycodone NDA: PMRS

Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA not to approve a pending Intellipharmaceutics NDA for oxycodone hydrochloride extended-release tablets with a proposed indication of “management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time.” The PMRS petition also asks that the agency refrain from approving all other pending or future applications for opioids indicated for chronic use, including use over an “extended period of time,” use for “long-term opioid treatment,” or any other labeling for chronic use.

If FDA were to approve the NDA, the petition says, the drug “would be misbranded and its presence on the market would negatively affect the public health, potentially fueling the current epidemic of opioid addiction.” It also says the drug’s proposed indication is “false and misleading, and lacks ‘substantial evidence consisting of adequate and well-controlled investigations’ as required by the Federal Food, Drug, and Cosmetic Act.” An earlier PMRS petition said that beginning with the approval of original Oxycontin in 1995, FDA “has unlawfully allowed extended-release opioids to be marketed with chronic-use labeling, despite a lack of evidence to support the chronic-use indication. Even today, there remains a lack of evidence that prescription opioids are effective or safe therapeutics in the chronic pain setting.”

PMRS, which has submitted an NDA for oxycodone immediate-release tablets with a proposed indication for managing acute pain, and not chronic use, contends that the “root cause of the United States opioid epidemic is FDA’s approval of opioid drug products for the treatment of chronic pain absent substantial evidence of efficacy.” It also claims that the drugs’ approved labeling gives the medical community false reassurance that opioids are safe and effective in treating chronic pain, despite a lack of evidence to support such an indication.

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