NexMed Files CMC Response with Health Canada for Vitaros(R)

SAN DIEGO--(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.
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