FDAnews Device Daily Bulletin

FDA ISSUES APPROVABLE LETTER IN RESPONSE TO APPLICATION FOR USE OF FUZEON WITH NEEDLE-FREE INJECTION DEVICE

Nov. 29, 2005
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Roche and Trimeris recently announced that the companies have received an approvable letter from the U.S. Food and Drug Administration (FDA), in response to their request for inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the Fuzeon (enfuvirtide) labeling. In the approvable letter, FDA has requested additional information from the ongoing ENF-404 or WAND (With A Needle-Free Device) study, a randomized, open-label, two-way, cross-over study assessing the tolerability of the B2000 device for administration of Fuzeon.

Life Sciences World (http://www.lifesciencesworld.com/news/news-Roche-and-Trimeris-FDA-Approval-6624.htm)