Ingredient in J&J's Imodium and numerous OTC generics acts on opioid receptors in the gut to slow movement in the intestines and decrease bowel movements, but dosing at much higher than recommended amounts can lead to serious problems including severe heart rhythm problems and death.
FDA is responding to an emerging threat that is an offshoot from the opioid abuse epidemic by suggesting single-dose packaging for OTC loperamide, an anti-diarrhea drug some people are using in significantly high dosages to prevent withdrawal symptoms.
Commissioner Scott Gottlieb said he also will ask online sellers of loperamide "to take voluntary steps to help us address...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
