FDA Rates Kitabis Pak as Therapeutic Equivalent of TOBI

RICHMOND, Va., March 16, 2015 /PRNewswire/ -- On Friday, the FDA listed Kitabis™ Pak as a therapeutic equivalent of TOBI^® (tobramycin inhalation solution, USP) in their Orange Book.  Kitabis Pak is listed with the AN designation meaning there are no known or suspected bioequivalence problems between Kitabis Pak and TOBI.

"It makes sense that the FDA listed Kitabis Park as therapeutically equivalent in the Orange Book, because TOBI was developed as tobramycin inhalation solution delivered with the PARI LC PLUS^® nebulizer," said Jan Zimmermann, portfolio manager for Kitabis Pak at PARI. "One prescription for Kitabis Pak ensures access to both tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, co-packaged and dispensed together. In addition, PARI initiated a compressor access program called PARI PROVIDE that is administered through a network of specialty pharmacies."

The FDA approved the New Drug Application for Kitabis Pak on December 2, 2014.  Kitabis Pak is a new standard for nebulized drugs where drug and nebulizer handset are co-packaged similar to asthma inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak is comparable to the price of generic tobramycin drug alone. 

"Our definitive goal is to ensure that patients with cystic fibrosis who are prescribed tobramycin inhalation solution also get the nebulizer handset that was used in clinical trials and approved for use with TOBI. Kitabis Pak accomplishes this goal and makes it easy for patients since they come together in an easy to understand kit," stated Lisa Cambridge, director of PARI's Medical Science & Pharmaceutical Alliances.

The FDA's Orange Book was first published in 1980 to respond to requests from states for a list of approved and therapeutically equivalent drugs to help make choices that can reduce drug costs.  Additional information is available online at fda.gov.

About Kitabis Pak
KITABIS PAK (co-packaging of tobramycin inhalation solution and the 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.

Full product and prescribing information on Kitabis Pak and PARI PROVIDE is online at: www.Kitabis.com.

About Cystic Fibrosis
Cystic fibrosis, a life-threatening disease affecting 30,000 American patients, involves a genetic mutation that results in poorly hydrated, thickened mucus secretions in the lungs.

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 PARI Respiratory Equipment, Inc.

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