www.fdanews.com/articles/179755-pediapharm-nabs-health-canada-approval-for-bacterial-ear-infection-treatment
Pediapharm Nabs Health Canada Approval for Bacterial Ear Infection Treatment
December 19, 2016
Pediapharm received Health Canada's marketing approval for Otixal to treat a bacterial infection of the middle ear in children.
The approval was based on two multicenter, randomized, double-blind Phase III trials, the Otixal treatment arms stopped ear discharge in shorter times than the ciprofloxacin and fluocinolone acetonide alone arms.
Pediapharm intends to launch Otixal in early 2017.