|
NEXMED CONFIRMS
FDA ACCEPTANCE OF NDA FOR ERECTLE
DYSFUNCTION PRODUCT
|
|
East
Windsor, NJ, November 20, 2007
-- NexMed, Inc. (Nasdaq: NEXM),
a developer of innovative transdermal
products based on its proprietary
NexACT® 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, Inc.
NexMed, Inc. is leveraging its
proprietary NexACT 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.
In September 2007, NexMed filed
a New Drug Application with the
FDA for its alprostadil treatment
for erectile dysfunction. 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
NexMed, 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 risks
and uncertainties that may individually
or mutually impact the matters
herein described, including,
but not limited to, obtaining
regulatory approval for its
products under development,
entering into partnering agreements,
pursuing growth opportunities,
and/or other factors, some of
which are outside the control
of the Company.
|
|
|
|
|
