Vitaros
Generic name: alprostadil
Treatment for: Erectile Dysfunction
NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
EAST WINDSOR, N.J.--(BUSINESS WIRE)--Nov 20, 2007 - NexMed, Inc., a developer of innovative transdermal products based on its proprietary NexACT(R) drug delivery technology, today announced that the New Drug Application (NDA) filed by the Company for its erectile dysfunction (ED) product, a topically applied alprostadil cream, was accepted for review by the U.S. Food and Drug Administration (FDA).
"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 CEO 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."
The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of eight months, should the FDA not require any additional studies or information.
About NexMed
NexMed, Inc. is leveraging its proprietary NexACT(R) drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed's novel, onychomycosis treatment, licensed to Novartis, is currently in pivotal Phase 3 trials in the U.S. and Europe. NexMed's pipeline also includes a Phase 2 treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information about the Company, go to www.nexmed.com.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to whether and when the FDA will approve the Company's ED Product.
Contact
NexMed, Inc.
Mark Westgate, CFO, 609-371-8123, ext 159
mwestgate@nexmed.com
or
Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
Posted: November 2007
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- NexMed Discusses End of Review Meeting for Vitaros - October 20, 2008
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- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment - September 24, 2007
Vitaros (alprostadil) FDA Approval History
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