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Bayer Cipro XR

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves Bayer's Cipro XR (ciprofloxacin extended-release) Dec. 13 for once-daily treatment of uncomplicated urinary tract infections (UTIs), giving the firm nearly one year to establish the extended-release product before Cipro faces patent expiration in December 2003. The indication was supported by an 891-patient study showing the safety and efficacy of 500 mg Cipro XR to be comparable to conventional 250 mg twice-daily Cipro. An application for complicated UTIs was submitted Oct. 29 (Pharmaceutical Approvals Monthly, Dec. 1, 2002, p. 20). Bayer is highlighting the convenience of the once-daily formulatio

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