A US FDA advisory panel will delve into the data of the PRECISION trial, which evaluated the cardiovascular risk of Pfizer Inc.'s Celebrex (celecoxib) compared to naproxen and ibuprofen, to determine if the study supports the cardiovascular safety of Celebrex. But the change that could come out of the meeting is a revision to the nonprescription labeling for naproxen and ibuprofen.
Celebrex CV Risk v. Naproxen, Ibuprofen: US FDA Does Not Recommend Differential Labeling
Advisory committee to evaluate whether PRECISION trial shows celecoxib cardiovascular safety is comparable to naproxen and ibuprofen and if naproxen and ibuprofen use should be contraindicated with aspirin.
More from US FDA Performance Tracker
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
• By
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
More from Regulatory Trackers
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.