The TOBI Podhaler (tobramycin inhalation powder) has been approved by the U.S. Food and Drug Administration to treat cystic fibrosis patients infected with Pseudomonas aeruginosa, a bacterium that can damage the lungs.
Cystic fibrosis, affecting about 30,000 people in the United States, causes production of thick, sticky mucus that builds up in the lungs. This can lead to chronic bacterial infections, the FDA said in a news release.
The TOBI Podhaler, used twice daily, was evaluated in clinical trials involving 95 adults and children six years and older with cystic fibrosis. The most common side effects included cough, coughing up blood, shortness of breath, fever, mouth and throat pain, changes in voice and headache.
The antibiotic inhaler is marketed by Novartis, based in East Hanover, N.J.