Teligent Receives FDA Approval of Fluocinonide Cream USP, 0.1 Percent

Teligent (NASDAQ:TLGT) has announced it has received approval for its abbreviated new drug application from the US Food and Drug Administration for its FLuocinonide Cream USP, 1.0 percent.

As quoted in the press release:

 This is Teligent’s fourth approval of 2019, and its thirty-sixth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

Based on recent IQVIA data from February 2019, the total addressable market for this product is approximately $17.3 million.

“Teligent continues to deliver on the promise of our pipeline with this latest approval,” commented Jason Grenfell-Gardner, President and CEO of the Company. “This was a first review cycle approval and was received ten months from filing. The filing contained paragraph IV certifications, however no action for infringement was brought against Teligent within the statutory 45-day period and therefore we plan to launch this product in the third quarter of 2019.”

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

Click here to read the full press release.