FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

Dec 11 2015

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 This is the Company's first product approved from the portfolio of discontinued and withdrawn new drug applications (NDAs) and abbreviated new drug applications (ANDAs), which the Company purchased from Astra Zeneca on September 25, 2014.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."