Teligent, Inc. Announces FDA Approval Of CEFOTAN® (cefotetan) For Injection

Product Launch in Early 2016 Will Address Current Drug Shortage

Dec 11, 2015, 08:00 ET from Teligent, Inc.

BUENA, N.J., Dec. 11, 2015 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's supplemental new drug application (sNDA) from the U.S. Food and Drug Administration (FDA) for CEFOTAN® (cefotetan) for Injection. This is the Company's first product approved from the portfolio of discontinued and withdrawn new drug applications (NDAs) and abbreviated new drug applications (ANDAs), which the Company purchased from Astra Zeneca on September 25, 2014.

"This FDA approval is a very important milestone for Teligent,'' commented Jason Grenfell-Gardner, President and CEO of the Company. ''The NDA for CEFOTAN® (cefotetan) for Injection that we purchased from Astra Zeneca had been discontinued from the market. Our organization quickly aligned to identify and address several activities that culminated in today's FDA approval. We are working closely with our manufacturing partner to launch the product in early 2016. We now have four approved injectable products in the United States, in addition to our seventeen injectable products marketed in Canada."

Mr. Grenfell-Gardner continued, "This FDA approval demonstrates continued execution of our TICO strategy, or topical, injectable, complex and ophthalmic strategy. Considering our two recently announced acquisitions of injectable products in Canada and the US, this approval marks our third injectable milestone in the fourth quarter of 2015. More importantly, this launch will allow us to address the drug shortage issues that this product has faced over the past year."

About CEFOTAN® for Injection, USP 

CEFOTAN® (cefotetan) for Injection, USP is available in two vial strengths. Each 1 gram vial contains cefotetan disodium equivalent to 1 gram cefotetan activity. Each 2 gram vial contains cefotetan disodium equivalent to 2 grams cefotetan activity.

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.


Jenniffer Collins

Teligent, Inc.

(856) 697-4379

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SOURCE Teligent, Inc.