Edition:
United States

Female Health Co (FHCO.PH)

FHCO.PH on Philadelphia Stock Exchange

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24 Apr 2017
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Latest Key Developments (Source: Significant Developments)

Female Health Co says new Tamsulosin DRS formulation advances to stage 2
Wednesday, 12 Apr 2017 08:30am EDT 

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.  Full Article

Female Health Co initiates bioequivalence clinical trial
Thursday, 9 Mar 2017 08:30am EST 

Female Health Co : The Female Health Company / Veru Healthcare initiates bioequivalence clinical trial comparing tamsulosin drs with flomax® . Female Health Co - expected nda approval would be sometime in mid to late 2018 . Goal is to have stage 1 clinical trial results completed by april 2017 . Female Health - stability data is being collected for commercial manufactured drug batches to allow an anticipated nda filing late 2017 / early 2018 .Female Health -initiated stage 1 of bioequivalence clinical trial designed to select optimal formulation of proprietary tamsulosin delayed release sachet product.  Full Article

The Female Health Co says plans to launch Preboost in U.S. before year-end
Thursday, 17 Nov 2016 11:00am EST 

Female Health Co : The Female Health Company / Veru Healthcare reports interim analysis of independent placebo controlled clinical study of Preboost, its proprietary premature ejaculation medication . Plans to launch Preboost in U.S. before year-end .Interim analysis results show that preboost improved both objective, subjective symptoms of premature ejaculation compared to placebo.  Full Article

Female Health and Aspen Park announce FDA clears pathway for expedited development of proprietary drug
Wednesday, 17 Aug 2016 08:30am EDT 

Female Health Co : Female Health Company and Aspen Park Pharmaceuticals announce FDA clears pathway for expedited development of proprietary drug . FDA also agreed with plans to conduct a single bioequivalence study to support filing of a NDA . Special meeting of FHC shareholders is scheduled for September 20, 2016 to approve matters relating to proposed merger .Intend to initiate a three week bioequivalence study in Q4 of this year and submit a NDA in 2017.  Full Article

The Female Health Company reports fiscal 2016 third quarter results
Thursday, 28 Jul 2016 08:30am EDT 

Female Health Co : The Female Health Company reports fiscal 2016 third quarter and first nine months operating results . Q3 earnings per share $0.02 .Q3 revenue $5.561 million.  Full Article

Female Health Company announces management change - Form 8k
Friday, 17 Jul 2015 03:45pm EDT 

Female Health Company:Says on July 10, Karen King, chief executive officer, president and a director left the company effective immediately.Says O.B. Parrish, the company's chairman of the board, was appointed effective July 10 to serve in the additional role of chief executive officer.  Full Article

More From Around the Web

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

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