Tobramycin, Nebulizer Combo Pack Approved for CF

The Food and Drug Administration (FDA) has granted approval for PulmoFlow’s Kitabis Pak, a combination package of Tobramycin Inhalation Solution and a PARI LC Plus Nebulizer. This is the first drug and device co-package to be approved for patients with cystic fibrosis ages ≥6 with Pseudomonas aeruginosa.

Tobramycin is an aminoglycoside antibacterial produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death. Tobramycin has in vitro activity against P. aeruginosa.

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Kitabis Pak is available in cartons containing one reusable PARI LC Plus Nebulizer and 14 Tobramycin Inhalation Solution pouches. Each pouch contains four 300mg/5mL ampules of Tobramycin. Pricing of Kitabis Pak will be similar to the price of generic Tobramycin alone.

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