EAST WINDSOR, N.J. The Food and Drug Administration has accepted for review, NexMed’s new drug application for an erectile dysfunction product, a topically applied alprostadil cream.
NexMed is working with its partner Warner Chilcott to gain regulatory approval for the treatment.
“We are pleased to announce the FDA’s acceptance of our submission for our ED product,” stated Vivian Liu, president and chief executive officer of NexMed. “We have already begun working with the agency and with our partner, Warner Chilcott, and look forward to gaining regulatory approval for this important new therapy. I am confident in Warner Chilcott’s chief executive officer Roger Boissonneault and his team’s ability to establish a major presence in urology. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product, upon its approval.”