Posted by Michael Wonder on 01 Aug 2019
Leo Pharma announces U.S. FDA expanded regulatory approvals for Enstilar foam and Taclonex topical suspension in treatment of plaque psoriasis
31 July 2019 - FDA approves Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; agency grants paediatric exclusivity extending U.S. market exclusivity.
LEO Pharma announced today the U.S. FDA has expanded the approved indication for 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 FDA granted Enstilar foam paediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to 10 December 2031.
This expanded indication is supported by the Enstilar Paediatric 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.
