Apricus Biosciences Announces Outcome of Vitaros™ End-of-Review Meeting with FDA
APRICUS BIOSCIENCES (APRI)
Last apricus biosciences earnings: 11/2 04:01 pm
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Source: GlobeNewswire
FDA Confirms Vitaros Regulatory Pathway Company Seeking Partner to Develop Vitaros in U.S. Company Evaluating Strategic Alternatives SAN DIEGO, April 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The preliminary end-of-review meeting minutes support a plan to address issues cited by the FDA in its February 15, 2018 Complete Response Letter (CRL) for the Vitaros NDA. Specifically, the FDA confirmed during the meeting that the company should develop a new Vitaros formulation that reduces the concentration of DDAIP.HCl from 2.5% to 0.5% in order to address the tumor promotion and partner transference safety concerns noted in th
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