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# Contepo PDUFA Date Accelerated
- URL: https://www.fdaweb.com/contepo-pdufa-date-accelerated/
- Published: 2019-01-15T12:00:00.000Z
- Updated: 2026-09-15T00:54:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143150

FDA has accelerated the PDUFA review date for Nabriva Therapeutics’ Contepo (fosfomycin for injection) from 6/30 to 4/30\. The company [says](https://investors.nabriva.com/news-releases/news-release-details/nabriva-therapeutics-provides-update-pdufa-date-intravenous?ref=fdaweb.com) the two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the 10/2018 Contepo NDA.

FDA has granted Contepo priority review, qualified infectious disease product, and fast track designations for treating several serious infections, including complicated urinary tract infections.

The company describes Contepo as a novel, potentially first-in-class in the U.S., intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant strains such as ESBL-producing Enterobacteriaceae.