RICHMOND, Va., Aug. 24, 2015 /PRNewswire/ -- Kitabis Pak, the first co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS Nebulizer for cystic fibrosis, was among ten notable drug-device approvals of 2014 published in the current issue of Drug Development & Delivery.
“Having Kitabis Pak recognized as a notable drug-device approval confirms PARI’s vision to make the prescription process for generic tobramycin and the PARI LC Plus nebulizer more convenient and cost effective for patients,” said Geoff Hunziker, president of PARI USA. “Since Kitabis Pak is one prescription for both the drug and nebulizer handset, it ensures patients receive the proper delivery device for tobramycin inhalation solution.”
The article, naming PARI LC Nebulizer as the integral part of the co-packaging, also summarized Kitabis Pak as the first defined drug-device combination approved for cystic fibrosis providing clarity for clinicians and patients with respect to optimal efficacy and safety with a defined formulation-device pairing.
“We have always believed that it is important for patients and healthcare professionals to understand that tobramycin inhalation solution is only approved for use with the nebulizer handset in Kitabis Pak,” said Jan Zimmermann, Portfolio Manager at PARI USA. “Being recognized in this category alongside other innovative pharmaceutical companies confirms our approach in setting a new standard of care for nebulized drugs.”
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.
Full product and prescribing information on Kitabis Pak 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 mission is to improve the lives of those affected by respiratory diseases and those who provide care for them. This is reflected in our comprehensive portfolio of innovative products and services.
Source: http://www.drug-dev.com/Uploads/Public/July%202015%20WEB%20FRIENDLY.pdf
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/kitabis-pak-one-of-ten-notable-drug-device-approvals-of-2014-300132165.html
SOURCE PARI Respiratory Equipment, Inc.
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