World 420_LB_03

Based on new information showing increased reporting of seizures in Bencontra patients with no prior history of seizures, Livyra is planning to update the prescribing information for Bencontra to include a specific warning relating to seizures as well as to make a corresponding update to the Highlights section to reflect the new warning. Can Livyra make these changes using a “changes being effected” supplement described in 21 CFR 314.70(c)(6)? In a message to the console, explain why or why not,...

The addition of a warning to Bencontra's prescribing information can be made using a “changes being effected” (CBE) supplement. However, a change to the Highlights section generally requires a prior approval supplement. At the same time, a labeling change ordinarily requiring a prior approval supplement may be included in a CBE supplement if specifically requested by the U.S. Food and Drug Administration (FDA). Additionally, the FDA can waive the requirement for a prior approval supplement. 

Absent such a request or waiver, Livyra’s proposed change to the Highlights section to reflect the new warning cannot be made using a CBE supplement.