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news.NexMed has received a non approvable letter from the FDA in response to its new drug application for its topical treatment for erectile dysfunction.
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The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.
Vivian Liu, president and CEO of NexMed, 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.”
Hem Pandya, vice president and COO of NexMed, said: “We plan to meet with the FDA and come to agreement on the necessary actions required in order to resubmit our NDA and resolve the deficiencies cited. We will also submit to the Agency final reports for two new, two-year carcinogenicity studies in both mice and rats, which were identified in the FDA’s letter as part of the information package needed to resolve the major deficiencies cited.”