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# ‘Complete Response’ for Motif Bio NDA
- URL: https://www.fdaweb.com/complete-response-for-motif-bio-nda/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143387

FDA has issued Motif Bio a complete response letter on its NDA for iclaprim for treating acute bacterial skin and skin structure infections. The letter indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved, according to the company. Motif Bio plans to request a meeting with the agency as soon as possible to discuss potential options to address the deficiencies.

The submission was based on data from REVIVE Phase 3 trials in patients who had wound infections, and showed that iclaprim was non-inferior to vancomycin in a pooled analysis of a subgroup of patients. The company says that iclaprim and vancomycin had similar adverse event profiles in patients with wound infections.