SAN DIEGO (AP) — Somaxon Pharmaceuticals Inc.has resubmitted its regulatory application for the insomnia drug candidate Silenor with the FDA and expects the review to take up to six months. In February, The FDA said it couldn’t approve the drug candidate without more information about the product. Somaxon said the FDA raised issues related to the data and interpretations of the drug’s effectiveness. The company included additional data on the drug candidate’s effectiveness with the resubmission and said it is confident the information “fully addresses” the FDA’s concerns.
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