NexMed, Inc. (NEXM) Meets with Food and Drug Administration (FDA) for Vitaros® Product
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…