Abbott Laboratories has received U.S. Food and Drug Administration (FDA) approval of a new seven-day indication for Biaxin XL (clarithromycin extended-release tablets) for the treatment of mild-to-moderate community-acquired pneumonia (CAP) in adults. Biaxin XL is the once-daily formulation of Abbott Laboratories' widely-prescribed, advanced-generation macrolide antibiotic, Biaxin (clarithromycin) tablets.
The study used in the approval of the new indication demonstrates that the clinical cure rate achieved with Biaxin XL is comparable to that achieved with a leading quinolone antibiotic, Levaquin (levofloxacin), in the treatment of CAP.
The newly-approved indication for Biaxin XL is for the treatment of mild-to-moderate CAP caused by Haemophilis influenzae, Haemophilis parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae (TWAR), and Mycoplasma pneumoniae.
"The similar efficacy of Biaxin XL in the clinical trial against a leading quinolone shows that Biaxin XL will provide a valuable treatment option for physicians in treating CAP," said Lee R. Weiss, M.D., F.A.C.E.P., clinical associate professor, Departments of Medicine and Emergency Medicine, Ohio State University School of Medicine, Columbus, Ohio. "It's important to have a number of treatment options to select from, however, health care providers need to ensure they are prescribing an antibiotic that provides an appropriate spectrum of coverage for CAP. This also means recognizing when to reserve some antibiotics for patients with more serious infections."
CAP is the most common type of pneumonia, which is an infection or inflammation of the lungs. Affecting two to three million Americans each year, CAP results in approximately 10 million physician visits annually. The most common symptoms of CAP include malaise, shaking chills, chest pain, weakness, fever, and a cough that produces rust or greenish-colored mucus. According to recent treatment guidelines for CAP issued by a working group from the Centers for Disease Control and Prevention (CDC), macrolides, including clarithromycin, are recommended as first-line treatment options for outpatients with CAP.