CPSE:NOVO BPharmaceuticals
FDA Warning On Ozempic Puts Novo Nordisk’s Compliance Risks In Focus
US FDA issued a formal warning letter to Novo Nordisk (CPSE:NOVO B) over shortcomings in safety monitoring and reporting for Ozempic and Wegovy.
The letter cites failures in procedures for capturing and reporting serious and unexpected adverse events in the US market.
Regulators are requiring corrective actions and have indicated that continued non compliance could trigger further enforcement.
Novo Nordisk, listed as CPSE:NOVO B, is a global pharmaceutical company focused on diabetes and...