January 03, 2017: Biotechnology firm Teligent 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%. These approvals were received on December 30, 2016, and brings Teligent’s total approvals from its internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.
November 30, 2016: Teligent announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Clobetasol Propionate Lotion 0.05%. This is Teligent’s sixth approval from its internally developed pipeline of topical generic pharmaceutical products.
Based on recent IMS Health data from October 2016, the total addressable market for this product is approximately $19.5 million. Teligent originally submitted this ANDA to the FDA in September 2015.
Jason Grenfell-Gardner, President, and CEO said, “Teligent received FDA approval for Clobetasol Propionate Lotion 0.05% in just less than fifteen months from our original submission date in September 2015. This is our second product approved from our pipeline of applications filed in Generic Drug User Fee Amendments (“GDUFA”) Year 3, which began on October 1, 2014. Teligent now has two products which have been approved by the FDA in a first round review, which exceeds current industry average review time periods published by the FDA in October of 2016. This is our thirteenth product in our domestic portfolio, and our commercialization team expects to launch this product in the first quarter of 2017.”
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Teligent, Inc., a specialty generic pharmaceutical company, develops, manufactures, and markets topical formulations in the United States.