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UPDATE 1-FDA extends Somaxon's insomnia drug review by 3 months

Mon Nov 24, 2008 8:40am EST

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Nov 24 (Reuters) - Specialty pharmaceutical company Somaxon Pharmaceuticals Inc (SOMX.O) said U.S. health regulators extended the review of its experimental insomnia treatment by up to three months.

But the regulators did not raise any issues with the data contained in the new drug application for the drug, Silenor, nor did they request any additional studies, the company said.

Somaxon also said it will undertake significant cost reduction measures and will continue to evaluate financing alternatives in order to ensure its financial position remains strong during the review period.

The U.S. Food and Drug Administration, which was supposed to complete the review of the drug by Dec. 1, said that the review would be extended for up to three additional months, requiring it to complete the review by Feb. 28.

Somaxon shares, which have lost more than 70 percent of their value over the last 12 months, closed at $1.75 Friday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Pratish Narayanan)



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