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BRIEF-Female Health Co says new Tamsulosin DRS formulation advances to stage 2
2017年4月12日 / 下午3点51分 / 5 个月前

BRIEF-Female Health Co says new Tamsulosin DRS formulation advances to stage 2

April 12 (Reuters) - Female Health Co :

* The Female Health Company / Veru Healthcare announces successful stage 1 of the clinical trial to evaluate bioequivalence between Tamsulosin DRS and FLOMAX®

* Planned NDA filing under 505(b)(2) regulatory pathway on track

* Results from stage 1 of be trial demonstrated that Tamsulosin DRS may have an improved safety profile

* In stage 2 of BE clinical trial, Tamsulosin DRS will be tested in a larger number of subjects versus FLOMAX

* Expected NDA approval would be sometime in second half of 2018 for Tamsulosin DRS Source text for Eikon: Further company coverage:

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