FDA Approves First Generic Ciprofloxacin Injection, USP

The Food and Drug Administration today 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. This approval is an important step in the agency's effort to increase the availability of lower-cost generic medications.

Ciprofloxacin (sip-row-FLOX-a-sin) 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."

The economic benefits of FDA's generic drug approval program are significant because generic drug products are used to fill over 50 percent of all prescriptions and can cost a fraction of the price of the brand name drugs. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending. The savings would likely increase as more competitors enter the market. (See www.fda.gov/cder/ogd/generic_competition.htm).

FDA's Office of Generic Drugs continues working expeditiously to review and take action on generic drug applications as quickly as possible. For more information on other first generic versions of innovator products, please see www.fda.gov/cder/ogd/approvals/1stgen0506.htm.

For additional information related to FDA's Office of Generic Drugs, please go to: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.