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news.Zogenix has announced that the company's new drug application for sumatriptan DosePro has been accepted for filing by the FDA for the acute treatment of migraine attacks with or without aura and cluster headache episodes.
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The FDA will take action on its application in late 2008. Sumatriptan DosePro (formerly known as Intraject sumatriptan) utilizes Zogenix’s proprietary DosePro needle-free drug delivery system to subcutaneously administer sumatriptan.
Roger Hawley, CEO of Zogenix, said: “We are very pleased to have our first new drug application (NDA) accepted for filing by the FDA. In just 18 months, we have progressed from a start-up stage company to one now with our first product under review by the FDA for approval.”