form complexes with amikacin that deactivate it. Liposome inhalation suspension Amikacin liposome inhalation suspension was the first drug approved under the US limited population pathway for antibacterial and antifungal drugs (LPAD pathway). It also was approved under the accelerated approval pathway. The U.S. Food and Drug Administration (FDA) granted the application for amikacin liposome inhalation suspension fast track, breakthrough therapy, priority review, and qualified infectious disease product (QIDP) designations. The FDA granted approval of Arikayce to Insmed, Inc. The safety and efficacy of amikacin liposome inhalation suspension, an inhaled treatment taken through a nebulizer, was demonstrated in a randomized, controlled clinical trial where patients were assigned to one of two treatment groups. One group of patients received amikacin liposome inhalation suspension plus a background multi-drug antibacterial regimen, while the other treatment group received a background multi-drug antibacterial regimen alone. By the sixth month of treatment, 29 percent of patients treated with amikacin liposome inhalation suspension had no growth of mycobacteria in their sputum cultures for three consecutive months compared to 9 percent of patients who were not treated with amikacin liposome inhalation suspension. References External links Aminoglycoside antibiotics Anti-tuberculosis drugs Breakthrough therapy Butyramides World Health Organization essential medicines Wikipedia medicine articles ready to translate Orphan drugs