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Though FDA released a draft guidance categorizing a range of labeling claims for abuse-deterrent opioids in January, there has been...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

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 
• By Francesca Bruce

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

More from North America

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 
• By Bridget Silverman

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.