Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, announced it has received approval of the company's abbreviated new drug application (ANDA) from the US 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.

"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,'' commented Jason Grenfell-Gardner, president and CEO of the company. "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."