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FDA Approves Kitabis Pak

FDA Approves PulmoFlow's Kitabis Pak Tobramycin & Nebulizer Combination for Cystic Fibrosis

RICHMOND, Va., Dec. 3, 2014 /PRNewswire/ -- 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.

About Kitabis Pak

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. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

About Cystic Fibrosis

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.

About PulmoFlow, Inc.

PulmoFlow, Inc. identifies unique opportunities in the field of respiratory indications with the aim to bring to market drug and device combinations that streamline the prescription process.

About PARI Respiratory Equipment, Inc.

PARI is a leading, worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, cystic fibrosis, RSV, VAP, and HAP. PARI's worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them. PARI is considered the gold standard for aerosol delivery for nebulizer therapies. Featured products include the PARI LC PLUS Reusable Nebulizer, Vortex Holding Chamber, and the drug-specific eFlow Technology platform.

SOURCE PulmoFlow, Inc.; PARI Respiratory Equipment, Inc.

Posted: December 2014

Kitabis Pak (tobramycin) FDA Approval History

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