pSivida Granted Waiver by the FDA for New Drug Application Filing Fee
PSIVIDA (PSDV)
Last psivida earnings: 2/7 04:02 pm
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Source: GlobeNewswire
WATERTOWN, Mass., Jan. 04, 2018 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products, today announced that the U.S. Food and Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million for its New Drug Application (NDA) for pSivida’s Durasert™ three-year microinsert for posterior segment uveitis. The Company remains on track to file the Durasert NDA in early January. “FDA’s grant of this waiver enables us to continue to focus our resources on initial preparations for our U.S. posterior segment uveitis launch anticipated in early 2019 and R&D activities in our product development pipeline,” commented Nancy Lurker, President and CEO. About pSivida Corp. pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release drug products for treating eye disease
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