Teligent, Inc. Announces Submission of Two Topical ANDAs

Total Teligent ANDAs on File at the FDA Reaches Thirty-One

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

BUENA, N.J., Dec. 17, 2015 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has submitted its twelfth and thirteenth abbreviated new drug applications (ANDAs) of 2015 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions now pending at the FDA to thirty-one.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "These are our fourth and fifth submissions in Generic Drug User Fee Act (GDUFA) year four, and the twelfth and thirteenth in 2015.  We still plan to submit an additional two to four ANDAs before the end of December 2015.  We believe our current pipeline of now thirty-one active submissions, exclusive of our four partnered submissions, pending approval by the FDA has a combined addressable market of over $1.6 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. For more information, please visit www.Teligent.com.

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

www.teligent.com

Logo - http://photos.prnewswire.com/prnh/20151113/287129LOGO

 

SOURCE Teligent, Inc.



RELATED LINKS

http://www.Teligent.com