Pfizer Discussing Trovan Labeling With FDA; Hepatic Injuries "Unpredictable"
Executive Summary
The unpredictability of liver injuries associated with use of Trovan (trovafloxacin) is the challenge facing Pfizer and the probable point-of-departure for discussions with FDA.
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Pfizer Trovan
FDA will add the injectable form of the antibiotic Trovan (alatrofloxacin) to its priority pediatric drug list for five infection types. The distribution of Trovan was recently limited in the U.S. to hospital use and five indications due to the emergence of unpredictable and severe liver injuries (1"The Pink Sheet" May 31, p. 9)