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FDA Approves Generic Forms of IV Ciprofloxacin


 

Several generic versions of the intravenous formulation of the widely used fluoroquinolone ciprofloxacin have been approved by the Food and Drug Administration, as part of what the agency says is its effort to make lower-cost generic drugs more widely available.

The generic formulations are versions of the trade formulation of Cipro IV, approved in 1991 and marketed by Bayer Corp. Ciprofloxacin injection is provided in a concentration of 10 mg/mL, and is packaged in 20-mL and 40-mL vials, and in a 120-mL pharmacy bulk package, according to an Aug. 28 FDA statement announcing the approval.

Drug Topics, an online magazine, listed Cipro IV injection as the top-selling drug in its list of the 200 highest-selling brand name drugs in the United States in 2005, according to the statement. The wholesale acquisition cost of the drugs used in hospitals totaled $115,353,072.

Ciprofloxacin injection is approved for treating infections caused by susceptible strains of designated microorganisms for certain infections in adults, including urinary tract infections, lower respiratory tract infections, nosocomial pneumonia, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, acute sinusitis, and empirical therapy in febrile patients with neutropenia. It is approved for treating complicated UTIs and pyelonephritis due to Escherichia coli, in patients aged 1–17 years, but not as a first choice, according to the Cipro IV label. It is also approved to reduce the incidence of inhalational anthrax after exposure to aerosolized Bacillus anthracis in adult and pediatric patients.

The approval of these generic versions of ciprofloxacin injection “can bring significant savings to the millions of Americans who have certain bacterial infections that can be treated with ciprofloxacin,” Gary J. Buehler, a pharmacist and director of the FDA's Office of Generic Drugs, said in the FDA statement. “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,” he added.

Other first-time generics approved by the FDA since June include formulations of the nonsteroidal anti-inflammatory drug meloxicam (Mobic), the antidepressant sertraline (Zoloft), and the cholesterol-lowering drug simvastatin (Zocor).

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