Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, announced that its Estonian subsidiary, Teligent OÜ, has received approval of the company's New Drug Submission (NDS) from Health Canada's Therapeutic Products Directorate for Gentamicin Injection USP 40mg/ml in 2ml ampoules. This is the first drug approval for Teligent OÜ and will be distributed by Teligent's business in Canada.

Based on internal estimates, the total addressable market for this product is approximately $1.9 million CAD.

"This product was filed with Health Canada less than a year ago and was accepted for priority review due to a product shortage in Canada," commented Jason Grenfell-Gardner, president and CEO of the company. "Our teams in Tallinn and Toronto are working closely with our contract manufacturing partner to bring this product to market in early 2017."