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FDA approves first generic ciprofloxacin injection, USP.

The FDA recently approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corporation Pharmaceutical Division's CIPRO I.V., a drug to treat certain bacterial infections.

Ciprofloxacin (sip-row-FLOX-asin) Injection, USP, is indicated for the treatment of infections, including urinary tract infections, lower respiratory tract infections (including pneumonias in hospitalized patients, nosocomial pneumonia), bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, and therapy of patients with fever and neutropenia.

In 2005, according to the online magazine, Drug Topics, CIPRO I.V. Injection was on the top 200 list of highest-selling brand-name drugs in the United States, with wholesale acquisition cost used in hospitals totaling $115,353,072. Ciprofloxacin Injection USP, 10 mg/mL, is packaged in 20 mL, and 40 mL vials and a 120 mL pharmacy bulk package, respectively. These products are manufactured by multiple generic companies.

"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, FDA's Office of Generic Drugs. "Ciprofloxacin Injection, USP, is a widely-used anti-microbial 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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Title Annotation:Industry News
Publication:Pharmaceutical Processing
Date:Oct 1, 2006
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