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TAP Spectracef approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cefditoren pivoxil clears FDA Aug. 29 for treatment of acute exacerbation of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections. Spectracef will be launched early in the fourth quarter, just ahead of the cold and flu season. When TAP originally submitted the NDA for the antibiotic in 1999, it also sought approval for sinusitis, but the firm voluntarily withdrew the indication and is no longer pursuing it

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