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Bayer Cipro gets pediatric exclusivity

Executive Summary

Bayer Cipro market exclusivity extended until June 9 after FDA grants six-month pediatric extension Dec. 18. Pediatric approval is based on 689-patient Cipro comparative trial; five-year, 1,029-patient observational study; and pharmacokinetic analysis. Although Bayer's patent expired Dec. 9, the product was protected by a 90-day review grace period following the Sept. 24 submission of the exclusivity application. Barr will continue to market its "authorized" ciprofloxacin generic through the pediatric exclusivity period (1"The Pink Sheet" Sept. 29, 2003, In Brief)...

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