FDA approves Kitabis Pak for Cystic Fibrosis-Pari
The FDA granted final approval of a New Drug Application for Kitabis Pak, from PulmoFlow, 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 available through Pari Respiratory Equipment, Inc.
Kitabis Pak 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.
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