Insite Files New Drug Submission With Health Canada
InSite Vision has filed a new drug submission with Health Canada seeking regulatory approval to market the topical ocular antibiotic AzaSite 1% for the treatment of bacterial conjunctivitis in Canada.
AzaSite was approved for bacterial conjunctivitis treatment by the FDA in April 2007, and was commercially launched in the US in August 2007 by Inspire Pharmaceuticals, AzaSite’s exclusive licensee in the US and Canada.
InSite has granted exclusive rights to Inspire to commercialize AzaSite for the treatment of ocular infections in the US and Canada in exchange for milestone payments and royalties for products sold in both countries.
Kumar Chandrasekaran, president and CEO of InSite, said: “This second filing is an important step in AzaSite worldwide commercialization, and will enable our partner Inspire to expand sales of AzaSite beyond the borders of the US.”