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US based pharmaceutical manufacturer NexMed Inc. have revealed that their latest product nearing the final stages of development has not been granted approval by the Food and Drug Administration, or FDA, within the Unites States. This news will be a big blow to the company who we're hoping to launch their erectile dysfunction product Vitaros, a revolutionary topically applied medication for the treatment of erectile dysfunction, later this year.
The major concerns which the FDA had with respect of Vitaros and the reason that they have ultimately declined to approve the treatment, which would have joined the ranks of Viagra, Cialis and Levitra, are based on the findings of a major transgenic mouse carcinogenicity study conducted by NexMed back in 2002.
Vivian Liu, the president and CEO of the pharmaceutical company NexMed when asked to comment on the recent verdict of the FDA on his product Vitaros said “The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost.”
Despite these latest developments NexMed remain positive with their outlook to the future as well as the potential release of other topically applied products currently nearing the final stages of development.