FDA approves first generic of Bayer's top-selling CIPRO I.V.
The US Food and Drug Administration has approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corporation's CIPRO I.V., used to treat certain bacterial infections.
The US Food and Drug Administration has approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corporation's CIPRO I.V., used to treat certain bacterial infections.
Ciprofloxacin Injection, (US Pharmacopoeia), is indicated for the treatment of infections, including urinary tract infections, lower respiratory tract infections, bone and joint infections, complicated intra abdominal infections, skin and skin structure infections, and therapy of patients with fever and neutropenia.
In 2005, the drug was among the 200 highest-selling brand-name drugs in the US and this approval is part of the FDA's effort to increase the availability of lower-cost generic medications.
"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 Buehler, director, 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."
Bedford Laboratories of Ohio, US, a division of Ben Venue Laboratories, has announced that it will begin marketing Ciprofloxacin Injection USP.