Teva’s Nuvigil Label-Expansion Effort Shows No Signs Of Fatigue Even After Bipolar Depression Failure
This article was originally published in Pharmaceutical Approvals Monthly
Attempts to expand armodafinil labeling have also included unsuccessful efforts in schizophrenia and jet lag, but Teva has more indications it would like to try with the wakefulness aid.
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After dropping efforts to obtain approval of Nuvigil (armodafinil) for treatment of jet lag disorder, Cephalon is left with one possible new indication for the wakefulness drug: depression associated with bipolar disorder.
Company tells “The Pink Sheet” DAILY it is set to begin studies in other therapeutic areas to boost labeling before commercial launch.
Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.