* SaysFDA to consider it Class 1 resubmission * Says FDA requires no additional data * Says FDA requires REMS data, medication guide * Shares up as much as 90 pct Jan 21 (Reuters) - Somaxon Pharmaceuticals Inc (SOMX.O) said it resubmitted data on its insomnia drug Silenor with the U.S. Food and Drug Administration, and the health regulator did not ask for additional safety or efficacy data on the drug. Somaxon, which met the FDA on Wednesday, said the regulator would consider the resubmission of data as a 'Class 1 resubmission' with a two-month review cycle. Somaxon said the regulator also reiterated that a revised Risk Evaluation and Mitigation Strategy, including a medication guide to be distributed with the product, will be required.[ID:nBNG503147] The company expects the FDA's decision by March 21 on Silenor, which has been refused approval twice already on issues regarding efficacy data. Shares of the company nearly doubled to $2.51 in after-market trade. They closed at $1.32 Thursday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Maju Samuel) Was nun, wieder alles risikieren oder raus und alles mitnehmen was man bekommen kann. |
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