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September 26

Since When Is Jet Lag a "Disorder"?

Did I miss something, or is the FDA now considering approving a drug for people who change time zones too quickly? What's next? Prescription-strength No-Doz for college kids?

I like the fact that Nuvigil is getting a priority review--you know, because "jet lag disorder" is an epidemic raging in the US that needs to be treated, stat!

http://philadelphia.bizjournals.com/philadelphia/stories/2009/09/21/daily38.html

Thursday, September 24, 2009, 12:19pm EDT

Cephalon seeking approval to market Nuvigil for jet lag

Philadelphia Business Journal - by John George Staff Writer

The Food and Drug Administration granted a priority review Thursday for Cephalon Inc.’s supplemental new drug application seeking to market Nuvigil for the additional use of treating jet lag disorder.

Frazer, Pa.-based Cephalon (NASDAQ:CEPH) already has approval to market Nuvigil to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder and narcolepsy. The product was launched in the United States in June.

Priority review status, which expedites the review of an application, is granted for products that represent a potential major advance in treatment for a condition where no adequate therapy exists.

A decision by the FDA is expected by Dec. 29. There currently is no FDA-approved treatment for jet lag disorder.

7:31 PM | Blog it | Health and wellness

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