Health Canada has a 45-day screening for acceptance process of the Rresponse 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.
Earlier, on January 19, 2010, NexMed had received a notice of non-compliance 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.
Bassam Damaj, president and CEO of NexMed, said: “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.”