Vitaros (alprostadil) refiled with the FDA for erectile dysfunction.-Apricus Biosciences.
Apricus Biosciences reported that it recently filed its resubmission of a New Drug Application (�NDA�) for Vitaros (alprostadil) with the FDA for the treatment of erectile dysfunction. Apricus anticipates a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) goal date in the first quarter of 2018, which it expects the FDA to acknowledge within 30 days of the NDA filing date.
Comment: this new potential entrant into the U.S. ED treatment market has been approved in Canada, Mexico and certain countries in Europe, Latin America and the Middle East and the product is being commercialized by Ferring International Center S.A. and its licensees throughout Europe and in the Middle East.
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