FDA Resistant to Replidyne Approval

The Food & Drug Administration's decision to require superiority studies for bronchitis and sinusitis antibiotic indications not only delayed the launch of faropenem by at least three years, it also cost Replidyne its commercial partner.

For an example of a drug held up by the Food & Drug Administration’s higher approval standard for antibiotics—and the commercial implications of that new environment—look no further than Replidyne Inc. ’s faropenem.

Last year, faropenem appeared to be on track for approval in 2006 in a variety of indications: acute bacterial sinusitis,...

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