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Apricus Won't Need New Trials To Resubmit ED Cream Vitaros At FDA

Executive Summary

After feedback on a very old complete response, biotech plans to resubmit a filing in the second half of 2017, instead of the fourth quarter, and will need to engage the Office of Product Quality because Vitaros is viewed as a drug/device combination.

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Nexmed sells US rights to topical ED treatment to Warner Chilcott

Nexmed has agreed to sell the US rights to Vitaros, a topical alprostadil cream for the treatment of erectile dysfunction, to its partnerWarner Chilcott.

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