Teligent Receives FDA Approval for 3 ANDAs

The FDA has approved 3 abbreviated new drug applications (ANDAs) from Teligent for nystatin and triamcinolone acetonide ointment (100,000 units/gram and 1 mg/gram), clindamycin phosphate topical solution (USP 1%), and flurandrenolide (USP 0.05%). The approvals were based on ANDAs submitted to the FDA on December 30, 2016.

Nystatin and triamcinolone acetonide ointment can be used to treat fungal infections on the skin. Its most common adverse effects are burning, itching, and irritation.

Clindamycin phosphate topical solution is indicated to treat vaginal infections caused by certain bacteria. Its most common adverse effect is vulvovaginal candidiasis.

Flurandrenolide, a topical adrenocortical steroid, can reduce skin inflammation. Its most common adverse effects are burning, itching, and irritation.

"Teligent received FDA approval for all 3 of these ANDAs on the last day of 2016, which marks a tremendous completion to a strong year for our team,” Jason Grenfell-Gardner, president and CEO of Teligent, said in a press release. “We now have 20 FDA-approved specialty generic prescription drug products in our domestic portfolio, evidencing the continued successful implementation of our development and diversification strategy.”

Teligent intends to launch all 3 of the products in the first quarter of 2017. The addressable market value for these items is about $73.6 million.