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GeneSoft Factive Surveillance Program Will Track Appropriate Prescribing

Executive Summary

GeneSoft will track Factive antibiotic prescribing patterns to determine whether labeling adequately promotes short-term use of the drug

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FDA Clears 21 NMEs In 2003; Average Approval Time Is 16.6 Months

FDA finished 2003 with slightly more new molecular entity approvals at a slightly faster pace than its 2002 performance

FDA Clears 21 NMEs In 2003; Average Approval Time Is 16.6 Months

FDA finished 2003 with slightly more new molecular entity approvals at a slightly faster pace than its 2002 performance

Factive supplemental approval

FDA approves GeneSoft's Factive (gemifloxacin) for use in community-acquired pneumonia in multi-drug resistant S. pneumoniae strains July 25 (1"The Pink Sheet" April 14, 2003, p. 15)...

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