Ultravate Indication Expanded to Include Pediatric Patients

August 27, 2020 – The U.S. FDA has approved an expanded indication for Ultravate® (halobetasol propionate) topical lotion, manufactured by Sun Pharmaceuticals. The product can now be used to provide topical treatment of plaque psoriasis for patients who are at least 12 years of age. Previously, it was approved only for use in patients age 18 and older.

An autoimmune condition, plaque psoriasis is the most common form of psoriasis. It occurs when the immune system attacks healthy skin cells. This causes the body to rapidly produce new skin cells in response, leading to the development of rough, discolored, scaly patches of thickened skin. Affected skin can become dry, itchy, cracked, and painful. Up to 40% of patients who develop psoriasis of any kind experience symptoms before the age of 16.

Approval of Ultravate’s expanded indication is based on the product’s safety and efficacy in adult patients, as well as a safety study of 16 patients ages 12-17. Under the recommended dosing, patients should apply a thin layer of Ultravate to affected skin twice daily until control of plaque psoriasis is achieved or for up to two weeks, whichever comes first.

If the patient experiences no improvement in their condition after two weeks, reassessment of diagnosis may be necessary. Treatment beyond two weeks is not recommended. The total dosage should not exceed 50g per week because of the potential for Ultravate to suppress the hypothalamic-pituitary- adrenal axis, which controls the body’s response to stress.

Ultravated first received FDA approval in 2015.