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FDA approves PulmoFlow's tobramycin and nebulizer combination for cystic fibrosis

MDBR Staff Writer Published 04 December 2014

The FDA granted final approval of PulmoFlow's New Drug Application for Kitabis Pak – a co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS Nebulizer.

This is the first nebulized drug and device combination to be approved for patients with cystic fibrosis. Kitabis Pak is in stock and available now through PARI Respiratory Equipment.

Kitabis Pak sets a new standard for nebulized drugs similar to asthma & COPD inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak will be similar to the price of generic tobramycin drug alone.

"Patient access to the only approved and proven delivery system for nebulized tobramycin is very important both for the patient and healthcare professional. Knowing that we don't have to worry about the device any longer is a huge benefit when we prescribe nebulized tobramycin," said Cheryl Velotta, LPN/CRT of UH Rainbow Babies and Children's Hospital.

"Our goal is to streamline the process so patients receive tobramycin inhalation solution with the nebulizer proven to deliver it effectively. Kitabis Pak is the easiest and most cost effective way for doctors to prescribe nebulized tobramycin without the added hassle of a separate nebulizer prescription or cost," added Geoff Hunziker, president of PARI USA.

In addition to exclusively marketing Kitabis Pak, PARI also offers a compressor access program called PARI PROVIDE for patients who do not have the proper compressor to deliver the tobramycin inhalation solution.

KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa.

Cystic fibrosis, a life-threatening disease affecting 30,000 American patients, involves a genetic mutation that results in poorly hydrated, thickened mucous secretions in the lungs, as well as severely impaired mucociliary clearance.



Source: Company Press Release