Teligent, Inc. Announces Eleventh ANDA Submission Of 2015

01 Dec, 2015, 08:00 ET from Teligent, Inc.

BUENA, N.J., Dec. 1, 2015 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its eleventh abbreviated new drug application (ANDA) 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 twenty-nine.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This is our third submission in Generic Drug User Fee Act (GDUFA) year four, and the eleventh in 2015.  We still plan to submit an additional four to six ANDAs before the end of December 2015.  We believe our current pipeline of now twenty-nine active submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of approximately $1.57 billion based on October 2015 data from IMS Health."

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 IGI Laboratories, 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.  IGI Laboratories, 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

www.teligent.com     

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SOURCE Teligent, Inc.



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