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FDA Approves Cephalon’s Nuvigil With Bolded Warning For Rash

This article was originally published in The Pink Sheet Daily

Executive Summary

Company tells “The Pink Sheet” DAILY it is set to begin studies in other therapeutic areas to boost labeling before commercial launch.

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Teva’s Nuvigil Label-Expansion Effort Shows No Signs Of Fatigue Even After Bipolar Depression Failure

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.

Teva’s Nuvigil Label-Expansion Effort Shows No Signs Of Fatigue Even After Bipolar Depression Failure

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.

FDA Pushes Back Action Date For Nuvigil Label Expansion Due To New Data

Cephalon, which has positioned Nuvigil to replace Provigil as the latter sleep drugs faces patent expiry, hopes to add treatment of jet lag to label.

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