NexMed Files CMC Response with Health Canada for Vitaros®
22 Abril 2010 - 7:50PM
Business Wire
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of
products based on the NexACT® technology, announced today that it
received delivery confirmation of its response to the CMC
(Chemistry, Manufacturing and Controls) concerns raised by Health
Canada (the “Response”). The Response is part of the review process
for its New Drug Submission (“NDS”) for Vitaros®, the Company’s
topical treatment for erectile dysfunction treatment, which was
filed in February 2008. Health Canada has a 45-day screening for
acceptance process of the Response by their Regulatory Project
Management group. The acceptance of the Response triggers a new,
150-day review cycle by the NDS reviewers for a final approval or
rejection of the marketing application.
On January 19, 2010, NexMed announced that it had received a
Notice of Non-Compliance (“Notice”) for its NDS pertaining to the
review by the New Drugs Quality Division of the Bureau of
Pharmaceutical Sciences. The Notice is a routine, end-of-review
communication from Health Canada issued when additional information
is required to reach final decision on product approval.
Dr. Bassam Damaj, President and Chief Executive Officer of
NexMed, stated, “NexMed met with Health Canada officials in
February 2010 to discuss the deficiencies cited in their Notice. At
that time, we were given guidance and reached agreement with the
regulatory officials on the additional information to be included
in our Response, which we then submitted in a timely manner. We
look forward to receiving Health Canada’s decision and continue to
be positive about the possibility of eventual product
approval.”
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and
is one of the industry's most experienced CROs for in vitro and in
vivo pharmacology services and research models. The Company’s goal
is to generate revenues from the growth of its Discovery
Pre-clinical CRO business, while aggressively seeking to monetize
its proprietary NexACT drug delivery technology through
out-licensing agreements with pharmaceutical and biotechnology
companies, worldwide. At the same time, NexMed is actively pursuing
partnering opportunities for its NexACT-based treatments for
onychomycosis, psoriasis, sexual dysfunction and cancer. For
further information on NexMed and its subsidiaries, visit the
following websites: http://www.nexmed.com or
http://www.bio-quant.com.
Forward-Looking Statement Safe
Harbor
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 for a
variety of reasons that are outside the control of the Company
including but not limited to obtain regulatory approval for
marketing Vitaros in Canada.
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