Drugs

Abuse Deterrent Remoxy NDA Resubmitted for Review

Pain Therapeutics has resubmitted to FDA an NDA for Remoxy (oxycodone) extended-release capsules, an abuse-deterrent formulation for treating pain. The submission was made despite Pfizer deciding in 2014 to discontinue its agreement to develop and commercialize Remoxy due to unresolved issues outlined in a 2011 complete response letter from the agency. Pfizer said at the time that its decsion was based on an “internal review of the top-line results of five recently completed clinical studies required to address the complete response letter...”

A complete response letter was also sent in 2008 that asked for more non-clinical data to support the drug's approval. That letter followed an FDA advisory committee vote (11 to 8) recommending approval, although it said Remoxy’s label should say that it is tamper-resistant rather than the abuse-resistant statement the company wanted.

Pain Therapeutics expects to be notified by FDA of a user fee review target date within 30 days. The original Remoxy NDA had a priority review designation, it notes.

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