positive results from Phase III study 4/09; a priority review was granted 9/09, with expected review by 12/29/09; PDUFA date delayed to 3/29/10; FDA denies drug, questioning robustness of data 3/10
Brand Nuvigil Generic armodafinil
Company name Cephalon Product type Non-speciality
Therapeutic category CNS Key uses excessive sleepiness associated with jet lag disorder
Other Uses malignant glioma, fibromylagia fatigue, cognitive dysfunction associated with schizophrenia, bipolar disorder Drug Class CNS stimulant
Dosage From oral Expected Approval 2010-Q4
FDA Filing N/A Last Update date March 30,2010
Link to news article
Link to clinicaltrials.gov