Resources for Food and Drug Administration (FDA)

FDA Knocks Neurocrine a Knuckle Sandwich

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If Neurocrine (Nasdaq: NBIX) were a boxer, the FDA would have delivered it a crushing uppercut this week. In a decision that Neurocrine described as "disturbing," "totally unanticipated," and "unprecedented" in a conference call, the FDA decided to issue Neurocrine's insomnia treatment indiplon a second approvable letter.

Neurocrine has been trying to get indiplon approved to help insomniacs fall asleep. It would compete with drugs like Sanofi-Aventis' (NYSE: SNY) Ambien franchise and Sepracor's (Nasdaq: SEPR) Lunesta in the multibillion-dollar sleep-drug market.

Following a May 2006 approvable letter, Neurocrine spent about a year meeting with the FDA and working on correcting the deficiencies the agency had cited, although it did not run any additional clinical trials.

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