Teligent, Receives FDA Approval of Clobetasol Propionate Gel, 0.05%

Teligent, a New Jersey-based specialty generic pharmaceutical company, has received approval of the company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Clobetasol Propionate Gel, 0.05%.  This is Teligent's second approval for 2017, and its thirteenth approval from its internally-developed pipeline of topical generic pharmaceutical medicines. 

Based on recent QuintilesIMS Health data from January 2017, the total addressable market for this product is approximately $10.9 million.

"We have received our second FDA approval in 2017 for Clobetasol Propionate Gel, 0.05%. We received this approval in just over 14 months after our submission in December 2015," commented Jason Grenfell-Gardner, President and CEO of the Company. "Teligent now has eighteen topical generic pharmaceutical products in the US portfolio, in addition to our four US injectable products. We expect to launch this product in the second quarter of 2017."