Vitaros(R), a topical treatment for erectile dysfunction based on the NexACT(R) technology, had been denied by the Food and Drug Administration (FDA) on July 21, 2008. Several points were made in the summary of key regulatory concerns. Those were: Overall Carcinogenicity Assessment, which includes the results from its three, two-year carcinogenicity studies in mice and rats, Assessment of the transfer to the partner of NexMed’s NexACT(R) technology, Assessment of transmission of sexually transmitted diseases (STDs), and GMP (Good Manufacturing Practices) Status of NexMed’s manufacturing facility.
In the meeting with the Food and Drug Administration (FDA) on October 15, 2008, NexMed has adequately addressed the deficiencies cited in FDA’s Pre-Approval Inspection and the FDA has revised the status from “withhold” to “acceptable.”
Vivian Liu, NexMed’s Chief Executive Officer commented, “We had a very productive meeting with representatives of the FDA. We now have a well-defined roadmap as to the actions necessary for addressing the deficiencies for our Vitaros(R) NDA prior to our Class 2 resubmission.”
NexMed Management will provide an update on the Vitaros(R) action items during its third quarter conference call on November 11, 2008, details of which will be issued closer to the date of the call.
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