This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAdditional telithromycin safety data requested by FDA will be submitted by mid-2002, the company tells analysts during an Aug. 2 conference call. Aventis is launching studies to provide the agency data on drug-resistant strains and rare side effects like QT prolongation and liver toxicity. Ketek was deemed "approvable" June 1 for community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis
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