Lundbeck receives FDA Complete Response Letter on Serdolect® for the treatment of schizophrenia
H. Lundbeck A/S (LUN.CO; LUN DC) announced today that the company hasreceived a Complete Response Letter (CRL) from the US Food and DrugAdministration (FDA) for Serdolect® (sertindole) for the treatment ofschizophrenia.The Agency's complete response included request for additional datato best understand the appropriate patient population for whichSerdolect® could be made available. Lundbeck is currently evaluatingthe feedback from FDA and will work with the Agency to resolve theseoutstanding questions and discuss appropriate next steps required tobring Serdolect® safely to market.