FDA Approves 3 Topical Treatments in Final Days of 2016

Abbreviated new drug applications were accepted for 3 topical generic products on December 30, 2016.

Teligent, a pharmaceutical company that manufactures specialty generic drugs, recently announced the FDA approved 3 of the company’s abbreviated new drug applications (ANDAs).

The topical products wereall approved on December 30, 2016, bringing the number of total approvals in the company’s pipeline of topical generic products to 9 last year, according to a press release from Teligent.

The FDA approved previous ANDAs for clobetasol propionate lotion 0.05%, and triamcinolone acetonide lotion USP, 0.1% and 0.025%, among others, Teligent reported.

More recently, the FDA approved ANDAs for nystatin and triamcinolone acetonide ointment USP, 100,000 units/gram and 1-mg/gram, clindamycin phosphate topical solution USP, 1%, and fluradrenolide ointment USP, 0.05%.

Nystatin and triamcinolone acetonide ointment USP is a topical drug used to treat fungal skin infections. Nystain, an antifungal, and triamcinolone, a corticosteroid, work together to reduce swelling, itchiness, and redness of skin associated with fungal infections, WebMD reported. Yeast infections of the skin are commonly treated with this ointment.

Clindamycin phosphate topical solution USP is anantibiotic used to treat patients with acne. It may also be used to treat other skin infections caused by bacteria and acne rosacea, according to WebMD.

Fluradrenolide ointment USP is used to treat various skin disorders that are characterized by itching, redness, dryness, crusting, scaling, inflammation, and discomfort, MedlinePlus reported.

Based on recent data from IMS Health, Teligent said that the market for these 3 drugs is approximately $73.6 million.

"Teligent received FDA approval for all three of these ANDAs on the last day of 2016, which marks a tremendous completion to a strong year for our team,'' said Jason Grenfell-Gardner, president and CEO of the company. "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. We now have twenty FDA-approved specialty generic prescription drug products in our domestic portfolio, evidencing the continued successful implementation of our development and diversification strategy. Just one year ago, our total domestic portfolio was only eleven products. Our commercialization team expects to launch all three of our new products in the first quarter of 2017."