Teligent Receives FDA Approval for Clobetasol Propionate Lotion ANDA
Teligent Inc. has announced the FDA approval of its Abbreviated New Drug Application (ANDA) for clobetasol propionate lotion (0.05%), a generic prescription drug. The product is sometimes referred to as Clobex, its registered name.
According to Galderma USA, which manufactures Clobex, the clobetasol propionate lotion can be used for the treatment of moderate-to-severe plaque psoriasis. The company also markets a spray version of Clobex. The most common adverse effects associated with the lotion are burning, stinging, skin dryness, irritation, and erythema.
"Teligent received FDA approval for Clobetasol Propionate Lotion 0.05% in just less than 15 months from our original submission date in September 2015,” Teligent President Jason Grenfell-Gardner said in a press release. “Teligent now has 2 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."
In clinical trials, 42.7% of patients who used Clobex achieved success, as defined by their score on the Global Severity scale of atopic dermatitis. They showed little or mild signs of erythema, induration/papulation, oozing or pruritus.
The clobetasol propionate in the lotion is a synthetic corticosteroid. Because it can be absorbed in the skin, it should not be used in excess. Doing so can result in the shutdown of the adrenal glands.