Teligent Announces FDA Approval of Diflorasone Diacetate Ointment 0.05%

- June 13th, 2018

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 Diflorasone Diacetate Ointment 0.05%. This is Teligent’s fifth approval for 2018, and its twenty-fourth approval from its internally-developed pipeline of topical generic pharmaceutical … Continued

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 Diflorasone Diacetate Ointment 0.05%. This is Teligent’s fifth approval for 2018, and its twenty-fourth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

As quoted in the press release:

Based on recent IQVIA data from April 2018, the total addressable market for this product is approximately $14.1 million.

“Diflorasone Diacetate Ointment 0.05% is Teligent’s fifth FDA approval in 2018,’’ commented Jason Grenfell-Gardner, President and CEO of the Company.  “This is another important approval for Teligent as we continue to drive growth in 2018 and beyond.  We are planning to launch this product in the third quarter of 2018.”

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

Click here to read the full press release.

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