Several hours of Tmax difference between brand Wellbutrin XL and generic bupropion is not critical to the drug’s efficacy given that it can take weeks to reach the drug’s desired effect, FDA determined.
Generics might be able to vary from branded drugs in terms of their Tmax by several hours, depending on how long it takes for the desired effect of the drug to kick in, FDA documents indicate.
FDA determined that several hours of difference in Tmax, the time required to reach the peak drug concentration, of bupropion are not considered meaningful to efficacy, since the desired effect...
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
