BioCentury
ARTICLE | Clinical News

Complete response letter for Motif's antibiotic

February 15, 2019 7:44 PM UTC

FDA issued a complete response letter to an NDA for iclaprim (MTF-100) from Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) to treat acute bacterial skin and skin structure infections (ABSSSIs). Motif said FDA indicated additional liver toxicity data are needed, and the company plans to request a meeting with FDA within 30-45 days to discuss options for addressing the agency's concerns...

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Motif Bio plc

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Dihydrofolate reductase (DHFR)