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Fly News Breaks for April 12, 2017
FHCO
Apr 12, 2017 | 09:01 EDT
The Female Health Company / Veru Healthcare announced the successful Stage 1 of a bioequivalence, or BE, clinical trial which was designed to select the optimal formulation of its proprietary Tamsulosin Delayed Release Sachet, or DRS, product. Tamsulosin DRS is a new, slow release oral powder formulation that addresses the large patient population of men with benign prostatic hyperplasia, or BPH, who have difficulty swallowing tablets or capsules. In Stage 2 of the BE clinical trial, Tamsulosin DRS will be tested in a larger number of subjects versus FLOMAX. Stability data is also being collected for the commercial manufactured drug batches to allow an anticipated late 2017/ early 2018 NDA submission. The expected NDA approval would be sometime in the second half of 2018.
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