The FDA has listed PARI’s Kitabis Pak in the Orange Book as a therapeutic equivalent of Novartis’s TOBI tobramycin inhalation solution with an AN rating, PARI has announced. Kitabis Pak, tobramycin inhalation solution packaged with a PARI nebulizer, was approved by the FDA for the treatment of P. aeruginosa infections in cystic fibrosis patients in December 2014.
PARI’s portfolio manager for Kitabis Pak, Jan Zimmermann, commented, “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. 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.”
Read the PARI press release.
