Drugs

Petition Seeks to Block Chronic-use Opioids

Pharmaceutical Manufacturing Research Services (PMRS) has petitioned FDA asking it to not approve any opioid product seeking an indication or any other labeling that suggests it is appropriate for chronic use. Specifically, the petition cited SpecGx’s MNK-812 (oxycodone), with relies on Roxicodone as the reference listed drug (see earlier story). PMRS says such submissions should not be approved “absent a meaningful demonstration of any such claims in compliance with a defined legal standard rather than mere reliance on methods unlawfully prescribed in the form of an FDA guidance document... If MNK-812 is approved with an indication that includes control of chronic pain, it would be misbranded and its presence on the market would negatively affect the public health, potentially further fueling the current epidemic of opioid addiction.”

PMRS submitted a 505(b)(2) NDA 1/2017 for oxycodone HCl capsules with a proposed indication for managing acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. PMRS’ says its proposed product is intended only for use in the management of acute pain and is not labeled for chronic use. The product’s package insert is proposed to include a statement informing physicians that the drug is formulated with inactive ingredients intended to make the capsule more difficult to manipulate for abuse, and that postmarketing epidemiology studies are required to demonstrate meaningful abuse-deterrent properties.

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