Drug news
CHMP recommends Quinsair for treatment of Cystic Fibrosis-pseudomonas aeruginosa-Aptalis/Actavis
On 18 December 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Quinsair from Aptalis/Forest, 240 mg, nebuliser solution intended for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with Cystic Fibrosis.
The active substance of Quinsair is levofloxacin, a fluoroquinolone antibacterial: J01MA12, acting by inhibition of bacterial DNA gyrase and topoisomerase IV enzymes.
A pharmacovigilance plan for Quinsair will be implemented as part of the marketing authorisation.Quinsair is known as Aeroquin in the US where it is in Phase III trials.