Drugs

Orexo Complete Response on Naloxone NDA

FDA has issued Orexo AB a complete response letter on its NDA for OX124, a high-dose naloxone rescue medication being developed for opioid overdose. The letter cites the need for an additional human factors (HF) study, and requests additional technical data on the final commercial product, according to the company, adding that the letter does not indicate a need for additional clinical or non-clinical studies.

“In response to the comments received in April 2024, Orexo has worked intensively to optimize the instructions of use,” the company says. “To meet the FDA requirement, a new HF study has been successfully completed. The requirement from FDA to provide additional technical data was unexpected, and Orexo will now work expeditiously in consultation with the FDA to address this to enable a resubmission of the NDA to FDA as soon as possible.”

OX124 is described as a high dose proprietary naloxone formulation and its rapid absorption and high bioavailability can reverse an overdose in a patient who has taken synthetic opioids.

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