Teligent Announces FDA Approval of Fluocinonide Ointment USP, 0.05%

Teligent (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Fluocinonide Ointment USP, 0.05%.

As quoted in the press release:

Based on recent IQVIA data from August 2018, the total addressable market for this product is approximately $­­17.8 million.

“With this most recent approval Teligent continues to prove its internal capabilities in developing and filing products,” commented Jason Grenfell-Gardner, President and CEO of the Company.  “Teligent continues to maintain an approval rate that places it in the top fifteen in the industry over the previous 12 months.  We are planning to launch this product in the fourth quarter of 2018.”

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

Click here to read the full press release.