The FDA has 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, according to a company news release.
The FDA green light makes Kitabis Pak the first nebulized drug and device combination to be approved for patients with cystic fibrosis. The product is being distributed through PARI Respiratory Equipment Inc.
Kitabis Pak is similar to asthma and 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, according to the company.
“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,” Cheryl Velotta, LPN/CRT of UH Rainbow Babies and Children’s Hospital said in a press release.
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.
Source: PulmoFlow Inc and PARI Respiratory Equipment Inc