PulmoFlow's nebulized drug and device combination gets FDA approval for cystic fibrosis

On Tuesday, the FDA granted final approval of PulmoFlow, Inc.'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, Inc.

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.

"The FDA approval and more than a decade of experience of using tobramycin solution for inhalation is based on the delivery by the PARI LC PLUS Nebulizer for safety and efficacy of treatment. No other nebulizer has been proven to be as safe or effective as the original," said Bruce Montgomery, M.D., former executive vice-president of Research & Development for TOBI®.

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.