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Neurocrine Makes New Case for Indiplon

Neurocrine Biosciences Inc. has resubmitted its 5-and 10-milligram sleeping pill capsules to the Food and Drug Administration after several months of interactions with the federal agency.

In May, the FDA essentially denied approval for 15-milligram tablets of Indiplon, which was expected to be the fiercest competitor to currently approved prescription sleeping aids. Chief Executive Officer Gary Lyons said the company is conducting tests, including one focused on the elderly population, for the 15-milligram tablets. He expects to resubmit that dose to the FDA in about two years.

With regard to the lower doses resubmitted June 12, the company has answered questions from the FDA about how Indiplon reacts with certain high-fat foods. Neurocrine said it has put together a “complete response to the May 15, 2006, approvable letter” issued by the FDA for the 5- and 10-milligram doses.

The company has around 300 employees after two rounds of layoffs last year that came as a result of the lukewarm reception at the FDA. Stock, which trades as NBIX on the Nasdaq, closed at $12.62 the day of the June 12 announcement, and was up nearly 3.5 percent in after-hours trading at $13.05.

, Katie Weeks

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