Teligent, a New Jersey-based specialty generic pharmaceutical company, said Wednesday it got approvals for three of its abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA). Shares climbed 3.6% intraday.
The permission was granted for 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%, according to a statement.
The approvals were received Dec. 30 and bring Teligent’s total from an internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.
Based on IMS Health data from November, the total addressable market for these three products is about $73.6 million, the statement added.
“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,” Jason Grenfell-Gardner, the CEO of Teligent, said. “We now have twenty FDA-approved specialty generic prescription drug products in our domestic portfolio.”