Teligent, Inc. Announces FDA Approval Of Lidocaine Ointment USP 5%

Feb 02, 2016, 08:00 ET from Teligent, Inc.

BUENA, N.J., Feb. 2, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Lidocaine Ointment USP 5%. This is Teligent's third approval from its internally developed pipeline of generic pharmaceutical products.

Based on IMS Health data from December 2015, the total addressable market for this product is approximately $327 million. Teligent submitted this ANDA to the FDA in February 2013.

"We received FDA approval for Lidocaine Ointment USP 5% in thirty-six months, which is well below the current FDA-reported median approval time for applications submitted prior to October 1, 2014 of 48 months,'' commented Jason Grenfell-Gardner, President and CEO of Teligent. "This FDA approval demonstrates continued execution of our TICO strategy, which is focused on the topical, injectable, complex and ophthalmic generic pharmaceutical markets. This is the eleventh product in our U.S. commercial portfolio, and we expect to launch this quarter." 

Mr. Grenfell-Gardner continued, ''We believe our current pipeline of thirty-two active submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of approximately $1.5 billion, based on December 2015 data from IMS Health."

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. For more information, visit www.Teligent.com.

Forward-Looking Statements

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.

Contact:

Jenniffer Collins

Teligent, Inc.

(856) 697-4379

www.teligent.com

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SOURCE Teligent, Inc.



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