Apricus Won't Need New Trials To Resubmit ED Cream Vitaros At FDA
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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Viagra marketer Pfizer also could have nonprescription sales in sight as it recruits a "global sexual health" brand manager with responsibilities including shepherding market expansion through an Rx-to-OTC switch.
Apricus Biosciences successfully confused its investors on Sept. 10 when the San Diego-based company announced that it managed to license its own topical treatment for erectile dysfunction (ED) from Allergan for a meager $1m upfront payment plus a future $1.5m regulatory milestone fee.
Nexmed has agreed to sell the US rights to Vitaros, a topical alprostadil cream for the treatment of erectile dysfunction, to its partnerWarner Chilcott.