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Biotech / Medical : CEPH - CEPHALON
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To: Cosmo Daisey who wrote (88)5/2/2006 7:17:11 AM
From: DewDiligence_on_SI   of 109
 
Cephalon Receives Approvable Letter for NUVIGIL

This is an unusual outcome in that the FDA is making the approval of Nuvigil, a single-isomer formulation of Provigil, contingent upon further review of Sparlon for ADHD, which is Provigil. This makes sense from a scientific standpoint, but I do not recall a case like this one where a drug was held up due to the FDA’s concerns about a parent compound.

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