Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Teligent, Inc. (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 Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort® Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc. This is Teligent's fourth approval from its internally developed pipeline of topical generic pharmaceutical products.

Based on recent IMS Health data from December 2015, the total addressable market for this product is approximately $17 million. Teligent originally submitted this ANDA to the FDA in November 2014.

"Teligent received FDA approval for Desoximetasone Ointment USP 0.25% in fifteen months in a first cycle review, which is consistent with the FDA's goals under the Generic Drug User Fee Amendments ("GDUFA"). This is our first product approved from our pipeline of applications filed under GDUFA Year 3, which began on October 1, 2014,'' commented Jason Grenfell-Gardner, President and CEO of the Company. "This FDA approval demonstrates continued execution of our TICO strategy, focused on the topical, injectable, complex and ophthalmic generic pharmaceutical markets. This is our twelfth product in our domestic portfolio, and our commercialization team expects to launch Desoximetasone Ointment USP 0.25% in 15g, 60g and 100g tubes in the second quarter of 2016. Based on December IMS Health data, the addressable market for our pipeline of now thirty-one ANDAs is estimated at $1.4 billion, excluding our four partnered submissions. Over 74% of the total addressable market in our pipeline relates to submissions filed in GDUFA Year 3 or later."

SOURCE Teligent, Inc.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
You might also like... ×
Small biotech companies join with pharmaceutical giants to manufacture drugs