Teligent, Inc. Announces FDA Approval of Fluocinonide Ointment USP, 0.05%
BUENA, N.J., Oct. 02, 2018 (GLOBE NEWSWIRE) -- 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 Fluocinonide Ointment USP, 0.05%. This is Teligent’s tenth approval for 2018, and its twenty-ninth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.
Based on recent IQVIA data from August 2018, the total addressable market for this product is approximately $17.8 million.
“With this most recent approval Teligent continues to prove its internal capabilities in developing and filing products," commented Jason Grenfell-Gardner, President and CEO of the Company. “Teligent continues to maintain an approval rate that places it in the top fifteen in the industry over the previous 12 months. We are planning to launch this product in the fourth quarter of 2018.”
Mr. Grenfell-Gardner continued, “We now have thirty-four topical generic pharmaceutical products in the US portfolio, in addition to our four US injectable products.”
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.