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FDA Advisory Committee supports use of tobramycin inhalation powder from Novartis for patients with cystic fibrosis
Date:9/5/2012

saved on setting up and maintaining the nebulizer and compressor.

The safety profile of TIP is similar to the profile of TOBI, other than local effects due to powder inhalation. In the Phase III clinical trial program, the most commonly reported adverse events with TIP were cough, lung disorder (i.e., CF/pulmonary exacerbations), increased sputum, dyspnea and pyrexia.

Tobramycin inhalation powder is approved in 38 countries, including the European Union, Canada, Switzerland and Australia. TIP is currently available in Canada and a number of countries in the European Union under the brand-name TOBI® Podhaler®. The proposed brand-name in the US, pending FDA approval, would be TOBI® Podhaler™.

TOBI® (tobramycin inhalation solution, USP) is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. TOBI has not been studied in patients under six years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION
If patients are allergic to antibiotics in the same family as TOBI (i.e., aminoglycosides), they should not take TOBI. They should tell their doctor before starting treatment if they have any history of hearing, kidney, balance, or muscle problems.

Patients taking TOBI may have temporary side effects like coughing or difficulty breathing. Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in voice (hoarseness). Ringing in the ears may be a warning sign for hearing loss. If patients have ringing in the ears, changes in hearing, or dizziness, they should tell their doctor.

In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage.

If patients are p
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SOURCE Novartis
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