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Purdue NDA For Oxycodone/Naloxone Combo Tests New FDA Policy

 
• By Cathy Dombrowski

The sponsor believes its data package could support a labeling claim that the drug “is expected to result in a meaningful reduction in abuse”; the agency’s review could indicate the strength of data needed to support such a claim.

FDA’s review of Purdue Pharma LP’s second abuse-deterrent opioid product, a combination of oxycodone and naloxone, could clue sponsors into the strength of data the agency is looking for to support a claim that an opioid drug “is expected to result in a meaningful reduction in abuse.”

Though FDA released a draft guidance categorizing a range of labeling claims for abuse-deterrent opioids in January, there has been...

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More from United States

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

More from North America

US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By Cathy Kelly

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 
• By Francesca Bruce

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.