NexMed, Inc.

NexMed Receives FDA Response for ED Product

Published in Medical Letter on the CDC and FDA, August 10th, 2008

NexMed, Inc. (Nasdaq: NEXM), announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.

Commenting on the announcement, Vivian Liu, President and Chief Executive Officer 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...

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Source: Medical Letter on the CDC and FDA (2008-08-10)

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