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pSivida plans to submit NDA for Medidur using 6-month efficacy data
pSivida plans to submit a new drug application to the FDA for Medidur to treat posterior uveitis, according to a press release. The NDA, expected to be submitted in the first half of 2017, will be based on 6-month efficacy data of Medidur (sustained-release micro-insert of fluocinolone acetonide) from two phase 3 clinical trials that the FDA said will be acceptable for review, the release said.