Novartis Canada has announced that it has received a Notice of Compliance from Health Canada for its TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The product has been approved for CF patients aged six and older.
The TOBI Podhaler has had orphan drug designation in the EU since 2003. According to the company, 3,800 CF patients live in Canada.
In September, 2010 the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended approval of a marketing authorization for the TOBI Podhaler in Europe.
Read the Novartis press release.
