Lundbeck's sertindole gets second chance with new NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Ten years after then-partner Abbott withdrew the NDA for sertindole due to concerns over the atypical antipsychotic's cardiovascular safety profile, Lundbeck submits the drug for treatment of schizophrenia with a new trade name, Serdolect, the company announces Sept. 15. FDA has accepted the NDA, the firm reports. Sertindole was submitted as Serlect in 1995 and became "approvable" the following year after a positive advisory committee recommendation. The 1998 NDA withdrawal was matched by a marketing suspension in Europe from 1998 to 2001 based on concerns regarding cardiac arrhythmia and sudden cardiac death