d******8
发帖数: 1972 | 1 FDA 刚刚通过了这个公司主打药物的非处方指导意见，不是批准。估计将来批准后会大
涨，可是风险是不是比较大？同一药物的处方药物已经上市。
Somaxon Pharmaceuticals, Inc. (Somaxon) is a specialty pharmaceutical
company focused on the in-licensing and development of product candidates
for the treatment of diseases and disorders in the central nervous system
therapeutic area. On March 18, 2010, the food and drug administration (FDA)
notified the Company that it approved its New Drug Application (NDA) for
Silenor (doxepin) three mlilligram and six milligram tablets for the
treatment of insomnia characterized by difficulty with sleep maintenance.
Silenor is an oral tablet formulation of doxepin at strengths of three
milligram and six milligram. Doxepin has been marketed from 75 milligram to
300 milligram per day and is indicated for the treatment of depression and
anxiety. The Company’s clinical development program for Silenor included
four Phase III clinical trials, and the primary efficacy endpoint achieved
statistical significance in each trial. |
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