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NSAID Panel Could Give Naproxen Labeling Edge

 
• By Cathy Dombrowski

FDA’s Arthritis and Drug Safety and Risk Management advisory committees on Feb. 10-11 will examine cardiovascular risk data for non-steroidal anti-inflammatory drugs, including meta-analyses indicating naproxen could have a better safety profile than other OTC ingredients ibuprofen and ketoprofen.

OTC non-steroidal anti-inflammatory drugs could end up on the path to labels differentiating the safety of naproxen from other NSAID ingredients after FDA’s Arthritis and Drug Safety and Risk Management advisory committees discuss the analgesics’ cardiovascular thromboembolic risk in a joint meeting Feb. 10 and 11.

The committees will discuss data collected since the two panels reviewed Rx and OTC NSAIDs in 2005, when FDA called...

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Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.