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# FDA Expanded OK for Leo Pharma’s Psoriasis Therapies
- URL: https://www.fdaweb.com/fda-expanded-ok-for-leo-pharmas-psoriasis-therapies/
- Published: 2019-08-01T12:00:00.000Z
- Updated: 2026-09-15T01:41:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144673

FDA has expanded the approval for Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The agency also granted Enstilar Foam pediatric exclusivity, extending it by an additional six months to 12/10/31, according to the company. The expanded indication is based on data from the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 with psoriasis of the body and scalp, as well as data from adequate and well-controlled trials in adults, Leo Pharma says. Additionally, FDA approved the company’s Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.