Lundbeck Serlect NDA Revival Is One Project For CEO-Elect Braestrup
Lundbeck CEO-elect Claus Braestrup will oversee the company's renewed attempt to launch the antipsychotic Serlect (sertindole) in the U.S. when he assumes leadership of the Danish company in November
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Forest memantine (Namenda) has a small but consistent effect in patients with moderate to severe Alzheimer's dementia, FDA's Peripheral & Central Nervous System Drugs Advisory Committee concluded Sept. 25
QT Interval Early Negative Signal Would Lessen Burden In Later Trials
QT interval prolongation may not need to be evaluated "intensively" in late phase trials if preclinical and Phase I studies do not show a positive signal, participants in a Drug Information Association workshop generally agreed
Pfizer Geodon QT Drug Contraindication Expanded, Clarified In New Labeling
Pfizer's Geodon should not be used by patients taking drugs that have a contraindication or boxed or bolded warning about QT prolongation, a labeling revision for the antypsychotic states