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approvable

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At this point, applications will fall into one of three categories--approved, approvable (showing clinical benefit) or not approvable.
In addition, the number of approvable letters, which state what conditions must be met for a drug to be approved increased.
For Novartis, excludes Invoelon and Pulminiq decisions as Novartis on longer (Inovelon) or not yet (Pulminiq) owned the project: Merck included Emend (2007); Roche includes Fuzeon (2007) (2) NMEs and non-NMEs (3) Indiplon counted as approvable (received approvable for 5/10mg immediate release and non-approvable for 15mg extended release (4) Accomplia/Zimulti counted as approvable (received approvable for weight management and non-approvable for smoking cessation) Source: Company reports .
 
 
 
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