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Trimethoprim-Like Antibiotic Fails to Meet FDA Panel Standard for Safety, Efficacy

COLLEGE PARK, Md. (EGMN) – Data from two phase III clinical trials failed to demonstrate that the antibiotic iclaprim is safe and effective for treating complicated skin and skin structure infections in adults, a Food and Drug Administration advisory panel found. The panel voted 16 to 2 at a Nov. 20 meeting and cited the need for more data on the drug’s effectiveness against non– gram-positive organisms, as well as concerns about prolonged QT intervals in a few patients.




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