FDA approval for Teligent’s Cefotan for injection

Shares of US specialty generics firm Teligent (Nasdaq: TLGT) dipped 3.88% to $8.83 in pre-market trading after the company reported the Food and Drug Administration has approved supplemental New Drug Application (sNDA) for the antibiotic Cefotan (cefotetan) for injection.

This is the company's first product approved from the portfolio of discontinued and withdrawn NDAs and abbreviated NDAs, which Teligent purchased from AstraZeneca (LSE: AZN) on September 25, 2014.

"This FDA approval is a very important milestone for Teligent,'' commented Jason Grenfell-Gardner, president and chief executive of the company, adding: ''The NDA for Cefotan (cefotetan) for Injection that we purchased from AstraZeneca 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."