The product is indicated for cystic fibrosis patients aged six years and older with chronic lung infection caused by P. aeruginosa.
An open-label active comparator study comparing the efficacy of Colobreathe to tobramycin nebuliser solution for inhalation has demonstrated the benefits and its ability to prevent deterioration of respiratory function in cystic fibrosis patients.
Colobreathe was well tolerated and there was no emergence of antibacterial resistance, the study reported.
Forest Laboratories Europe CEO Raymond Stafford said the company plans to introduce Colobreathe first in Germany by mid 2012 closely followed by other European countries and the UK in September 2012.