Teligent Announces FDA Approval of Fluocinonide Gel, 0.05%

Teligent (NASDAQ:TLGT) has announced it has received US FDA approval of its new drug application of FLuocinonide Gel, 0.05 percent.

As quoted in the press release:

 This is Teligent’s sixth approval for 2018, and its twenty-fifth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

Based on recent IQVIA data from April 2018, the total addressable market for this product is approximately $6.2 million.

“Fluocinonide Gel, 0.05% is Teligent’s sixth FDA approval in 2018,’’ commented Jason Grenfell-Gardner, President and CEO of the Company.  “This is yet another demonstration of Teligent’s ability to successfully develop products internally and to get those products successfully through the approval process.  We are planning to launch this product in the third quarter of 2018.”

Mr. Grenfell-Gardner continued, “We now have thirty topical generic pharmaceutical products in the US portfolio, in addition to our four US injectable products.”

Click here to read the full press release.