Teligent, Inc. announces FDA approval for three abbreviated new drug applications.
Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, announced it has received approval of three of the company’s abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, Clindamycin Phosphate Topical Solution USP, 1% and Flurandrenolide Ointment USP, 0.05%.
The approvals were received on December 30, 2016 and bring Teligent’s total approvals from its internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.
Based on recent IMS Health data from November 2016, the total addressable market for these three products is approximately $73.6 million.
“Teligent received FDA approval for all three of these ANDAs on the last day of 2016, which marks a tremendous completion to a strong year for our team,” commented Jason Grenfell-Gardner, president and CEO of the company. “In addition, our partner received approval for Flurandrenolide Lotion USP, 0.05%, a product we developed and submitted for them and we anticipate manufacturing that product for our partner in the coming weeks.
“We now have twenty FDA-approved specialty generic prescription drug products in our domestic portfolio, evidencing the continued successful implementation of our development and diversification strategy,”Grenfell-Gardner added. “Just one year ago, our total domestic portfolio was only eleven products. Our commercialization team expects to launch all three of our new products in the first quarter of 2017.”
(Source: PR Newswire)