Description

The proposed indication for Tobramycin 28 mg inhaler is for the management of cystic fibrosis patients with Pseudomonas aeruginosa. There are two approved products for the management of Pseudomonas aeruginosa in patients with CF; the approved indication varies for these two products although their clinical use is similar. Both are inhaled liquid formulations administered by inhalation with nebulizers. TOBRAKZA® is a tobramycin solution formulated for inhalation via a nebulizer and compressor. It is specifically indicated for use with the Pari LC Plus nebulizer and Pulmoaide air compressor. The treatment dose is 300 mg inhaled delivered twice daily. TOBI® is taken for repeated cycles of 28 days on drug and 28 days off drug.