Teligent, Inc. Announces FDA Approval Of Desoximetasone Ointment USP 0.25%

Feb 26, 2016, 08:00 ET from Teligent, Inc.

BUENA, N.J., Feb. 26, 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) of Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort® Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc. This is Teligent's fourth approval from its internally developed pipeline of topical generic pharmaceutical products. 

Based on recent IMS Health data from December 2015, the total addressable market for this product is approximately $17 million. Teligent originally submitted this ANDA to the FDA in November 2014.

"Teligent received FDA approval for Desoximetasone Ointment USP 0.25% in fifteen months in a first cycle review, which is consistent with the FDA's goals under the Generic Drug User Fee Amendments ("GDUFA"). This is our first product approved from our pipeline of applications filed under GDUFA Year 3, which began on October 1, 2014,'' commented Jason Grenfell-Gardner, President and CEO of the Company. "This FDA approval demonstrates continued execution of our TICO strategy, focused on the topical, injectable, complex and ophthalmic generic pharmaceutical markets. This is our twelfth product in our domestic portfolio, and our commercialization team expects to launch Desoximetasone Ointment USP 0.25% in 15g, 60g and 100g tubes in the second quarter of 2016. Based on December IMS Health data, the addressable market for our pipeline of now thirty-one ANDAs is estimated at $1.4 billion, excluding our four partnered submissions. Over 74% of the total addressable market in our pipeline relates to submissions filed in GDUFA Year 3 or later."

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.

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.

Topicort® is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.


Jenniffer Collins

Teligent, Inc.

(856) 697-4379

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SOURCE Teligent, Inc.