pSivida Granted Waiver by the FDA for New Drug Application Filing Fee
pSivida Corp. announced that the 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.
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