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news.NexMed has received a Notice of Non-Compliance as part of the review process from Health Canada, for its New Drug Submission (NDS) for the Vitaros erectile dysfunction treatment filed in February 2008. The deficiencies cited were related to the product’s CMC (Chemistry, Manufacturing and Controls). There were no pre-clinical or clinical deficiencies cited in the notice.
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The notice is a routine end-of-review communication from Health Canada when additional information is needed to reach final decision on product approval.
NexMed has 90 days from the date of the notice to respond to Health Canada, followed by the Health Canada 45 day screening process in the Regulatory Project Management group, and then a 150 day review cycle by the NDS reviewers.
Bassam Damaj, CEO of NexMed, said: “The Notice provides us with a clear pathway to obtaining marketing approval of the product in Canada. The FDA had previously raised most of Health Canada’s CMC issues and we were successful in working out a compliance plan with them.
“We look forward to discussing Health Canada’s specific concerns in a face-to face meeting which will be our first since we filed the NDS. In the meantime, we remain optimistic about the approvability of our Vitaros product in Canada.”