FDA APPROVES FIRST GENERIC CIPROFLOXACIN
The FDA has approved several abbreviated new drug applications (ANDAs) for generic versions of Bayer's CIPRO I.V., a drug to treat certain bacterial infections. This approval is part of the agency's effort to increase the availability of lower-cost generic medications.
Ciprofloxacin for injection is indicated for the treatment of infections -- including urinary tract infections, lower respiratory tract infections, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections -- and for patients with fever and neutropenia. The drug is packaged in 20- and 40-mL vials and a 120-mL pharmacy bulk package.
According to Drug Topics, in 2005 CIPRO I.V. was one of the top 200 highest-selling brand drugs in the U.S.