BUENA, N.J., Dec. 31, 2015 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has submitted its fourteenth and fifteenth abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company’s total number of ANDA submissions now pending at the FDA to thirty-three.
Jason Grenfell-Gardner, President and CEO of the Company, commented, “We have now submitted seven ANDAs in Generic Drug User Fee Act (GDUFA) year four, and a total of fifteen in 2015. Our team has come together to exceed total 2014 submissions by thirty-six percent, while responding to the unprecedented, blistering pace of communications from the US FDA in 2015. We remain optimistic that these efforts will result in ANDA approvals in the first half of 2016. We believe our current pipeline of thirty-three active submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of approximately $1.7 billion based on November 2015 data from IMS Health.”
The Company noted that all ANDA submissions announcements in 2016 will be included in its periodic quarterly reports.
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.
Contact: | Jenniffer Collins |
Teligent, Inc. | |
(856) 697-4379 | |
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SOURCE Teligent, Inc.
