FDA approves generic version of inhalational anthrax antibiotic

The U.S. Food and Drug Administration approved the first generic versions of Levaquin (Levofloxacin ) Monday.

Levofloxacin is an antibiotic approved to treat certain infections in people ages 18 and older, including inhalational anthrax.

Levofloxacin is also used to treat mild, moderate or severe bacterial infections of the sinuses, bladder, prostate, skin and kidneys caused by specific germs, and is used to treat certain bacterial infections that can cause pneumonia or bronchitis.

"Generic drugs are important options that allow greater access to health care for Americans," Keith Webber, the deputy director at the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, said. "FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product."

Levofloxacin is part of a class of drugs called fluoroquinolones, which are associated with an increased risk of tendinitis and tendon rupture, especially in those older than 60, in patients taking corticosteroid drugs, and in those with kidney, heart or lung transplants. The boxed warning also has an alert that the drug may worsen muscle weakness in people with myasthenia gravis, a chronic autoimmune neuromuscular disease.

The oral solution, generic tablet and injectable solution dosage forms of levofloxacin have been approved under 12 manufacturer’s applications.

Inhalation anthrax infection is currently treated with a 60 day course of antibiotics, according to the Centers for Disease Control and Prevention.