BUENA, N.J., Aug. 23, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today 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."
About Teligent, Inc.
Teligent is a specialty generic pharmaceutical company. Our mission is to be a leading player in the specialty generic prescription drug market. Learn more on our website www.teligent.com.
This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue," "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in Teligent, Inc.'s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission. Teligent, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.
SOURCE Teligent, Inc.