Cephalon Completes PROVIGIL Label Revision

Armen Hareyan's picture
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Cephalon, Inc. (Nasdaq: CEPH) announced that it has finalized and shared with healthcare professionals revisions to the label for PROVIGIL (modafinil) Tablets [C-IV], its wake-promoting agent. As announced by the company in both March and June of this year, these changes were necessary to make the PROVIGIL label consistent with the NUVIGIL(TM) (armodafinil) Tablets [C-IV] label approved and made available by the U.S. Food and Drug Administration (FDA) in June 2007. NUVIGIL is the single isomer formulation of modafinil, the active ingredient contained in PROVIGIL. The labels for PROVIGIL and NUVIGIL can be found on cephalon.com.

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PROVIGIL and NUVIGIL each are indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder and narcolepsy. In OSAHS, PROVIGIL and NUVIGIL are indicated as adjuncts to standard treatment(s) for the underlying obstruction. PROVIGIL and NUVIGIL are not approved for use in pediatric patients for any indication.

Cephalon's ongoing development program is evaluating the use of NUVIGIL as a treatment for serious psychiatric and neurological medical conditions. The company currently plans a commercial launch of NUVIGIL once additional clinical data has been amassed.

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