Drug Development

Cephalon Provides Update Related to Nuvigil New Drug Application

Published in Medical Verdicts and Law Weekly, April 19th, 2007

Cephalon, Inc. (NASDAQ:CEPH) announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Nuvigil(TM) (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).

The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking modafinil and armodafinil. As expected, the agency also has indicated that it will request similar language in the label...

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Source: Medical Verdicts and Law Weekly (2007-04-19)

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