FIRST GENERIC CIPRO IV GET FDA GREEN LIGHT

Pharmacy Times, Volume 0, 0

The FDA approvedseveral abbreviatednew drug applicationsfor generic versions ofCipro IV (ciprofloxacinfor intravenous [IV]infusion), Bayer Pharmaceuticals' potentinjectable treatmentfor bacterial infections. Citing estimatesthat US hospitals spent more than $115million for the IV drug in 2005, FDA officialscalled its approvals for multiple genericversions an important step in reducing thenation's medication costs.

"These approvals are another exampleof our agency's efforts to increase accessto safe and effective generic alternativesas soon as the law permits," said Gary J.Buehler, director of the FDA's Office ofGeneric Drugs. "Ciprofloxacin injection,USP, is a widely used antimicrobial agent,and the approval of several generic versionsof this drug product can bring significantsavings to the millions of Americanswho have certain bacterial infections thatcan be treated with ciprofloxacin."