FDA Advisory Committee Backs New Form of CF Drug
September 7, 2012
A U.S. Food and Drug Administration outside advisory panel has backed a new form of the CF drug TOBI® (tobramycin solution for inhalation).
The panel of advisers voted 13 to 1 that Novartis, the drug’s manufacturer, had demonstrated that its tobramycin inhalation powder (TIP), was safe and effective for the treatment of CF patients whose lungs contain Pseudomonas aeruginosa. This bacteria is the leading cause of lung damage in cystic fibrosis patients.
TIP can be taken with an inhaler, making it a convenient alternative to the older version of the drug, TOBI, which must be taken using a nebulizer. Novartis is seeking approval of the antibiotic powder.
Read the story from Reuters news service.