NexMed receive non approvable letter for topical alprostadil

NexMed have received a non approvable letter from the US FDA in response to its NDA for its topical alprostadil product Alprox-TD for for the treatment of 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.