FDA approves Novartis' TOBI Podhaler and Cangene's first Botulism Antitoxin heptavalent

The US Food and Drug Administration on Friday approved Swiss drug major Novartis’ (NOVN: VX) TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.

TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.

"This is good news for the CF community," said Robert Beall, president and chief executive of the Cystic Fibrosis Foundation, quoted by Novartis. "Managing daily CF treatments is a challenge for people with CF. TOBI Podhaler helps relieve that burden by shortening the time it takes to administer the medicine and making it easy for people with CF to take their treatment with them wherever they need to go," he added.