Teligent, Inc. Receives Two FDA Approvals For Topical Prescription Portfolio

BUENA, N.J., July 8, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, announced today that it has received approvals of the Company's abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) for both Triamcinolone Acetonide Lotion USP, 0.1% and Triamcinolone Acetonide Lotion USP, 0.025%.  The FDA has now approved seven ANDAs from the Company's internally developed pipeline of topical generic pharmaceutical products.

Based on IMS Health data from May 2016, the total addressable market for these two products is approximately $6.8 million.

"We are excited to add these two new products to our growing portfolio of topical prescription medicines," commented Jason Grenfell-Gardner, President and CEO of the Company.  "We have now received six approvals from the FDA this year, including an earlier approval of a partnered submission. Our team is committed to bringing these products to market this quarter.''

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.

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.

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SOURCE Teligent, Inc.

Related Links

http://www.teligent.com