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news.Pharmaceutical firm NexMed said that its new drug application for its erectile dysfunction product, a topically applied alprostadil cream, was accepted for review by the FDA.
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The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of eight months, should the FDA not require any additional studies or information.
Vivian Liu, president and CEO of NexMed, said: “We have already begun working with the agency and with our partner, Warner Chilcott, and look forward to gaining regulatory approval for this important new therapy. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product, upon its approval.”