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ARTICLE | Clinical News

FDA moves up PDUFA for Nabriva's Contepo by two months

January 18, 2019 8:04 PM UTC

Nabriva Therapeutics plc (NASDAQ:NBRV) said FDA accelerated its review timeline for Nabriva's broad-spectrum antibiotic Contepo fosfomycin, moving the NDA's PDUFA date to April 30 from June 30.

Nabriva said the accelerated timeline is "due to a clarification of the classification and subsequent expedited review." The company had announced on Jan. 4 that FDA accepted and granted Priority Review for the NDA, submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act...

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