FIRST GENERIC CIPRO IV GET FDA GREEN LIGHT

OCTOBER 01, 2006

The FDA approved several abbreviated new drug applications for generic versions of Cipro IV (ciprofloxacin for intravenous [IV] infusion), Bayer Pharmaceuticals' potent injectable treatment for bacterial infections. Citing estimates that US hospitals spent more than $115 million for the IV drug in 2005, FDA officials called its approvals for multiple generic versions an important step in reducing the nation's medication costs.

"These approvals are another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "Ciprofloxacin injection, USP, is a widely used antimicrobial agent, and the approval of several generic versions of this drug product can bring significant savings to the millions of Americans who have certain bacterial infections that can be treated with ciprofloxacin."



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