FDA Approves New Powder form of Novartis TOBI

A dry powder form of the antibiotic TOBI – TOBI Podhaler (tobramycin inhalation powder) – used to treat lung infections caused by the bacteria Pseudomonas aeruginosa has been approved by the US Food and Drug Administration (FDA).

People with CF ages six and older who have Pseudomonas aeruginosa  and whose lung function (FEV1) is between 25 percent and 80 percent predicted can use the new Novartis treatment. 

TOBI Podhaler does not require a nebulizer, does not need to be stored in a refrigerator, and does not require a power source to operate the inhaler. Administered with a pocket-sized inhaler, the new dry powder shortens treatment time by about 70 percent.  

Novartis anticipates the availability of TOBI Podhaler in the United States in the second quarter of 2013. 

Read the full Novartis press release here.