- Apricus Biosciences (APRI -0.7%) has refiled a New Drug Application (NDA) with the FDA seeking approval for Vitaros (alprostadil), an on-demand topical cream for the treatment of erectile dysfunction. If accepted for review, the agency's action date should be sometime in Q1 2018.
- The company received a CRL in 2008 in response to its original submission. It is commercially available in the EU and Canada.
- Previously: Apricus Bio expects to resubmit Vitaros NDA next year; now considered drug-device combination; shares down 22% premarket (Nov. 18, 2016)
Apricus resubmits U.S. marketing application for ED cream Vitaros
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