BUENA, N.J., Nov. 30, 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 Clobetasol Propionate Lotion 0.05%. This is Teligent's sixth approval from its internally developed pipeline of topical generic pharmaceutical products.
Based on recent IMS Health data from October 2016, the total addressable market for this product is approximately $19.5 million. Teligent originally submitted this ANDA to the FDA in September 2015.
"Teligent received FDA approval for Clobetasol Propionate Lotion 0.05% in just less than fifteen months from our original submission date in September 2015. This is our second product approved from our pipeline of applications filed in Generic Drug User Fee Amendments ("GDUFA") Year 3, which began on October 1, 2014,'' commented Jason Grenfell-Gardner, President and CEO of the Company. "Teligent now has two products which have been approved by the FDA in a first round review, which exceeds current industry average review time periods published by the FDA in October of 2016. This is our thirteenth product in our domestic portfolio, and our commercialization team expects to launch this product in the first quarter of 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.
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SOURCE Teligent, Inc.