Discontinued label guidance
Executive Summary
FDA guidance on allowing ANDAs to reference discontinued labeling from listed drugs is understood to be under review by the office of Chief Counsel Daniel Troy. The guidance would affect the approval of generic versions of drugs that have been recently re-labeled. Pediatric labeling changes are delaying approval of generics for Bristol's BuSpar and Glucophage (1"The Pink Sheet" Oct. 1, p. 26)