Pediatric exclusivity Archives

FDA Greenlights UCB Drug for Severe Form of Epilepsy

Approvals, Children, Clinical Trials, Epilepsy, Expanded Approval, Expanded Indication, FDA, Lennox-Gastaut Syndrome (LGS), Pediatric exclusivity, R&D, Seizures, Therapeutics, UCB

UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.

March 28, 2022/by BioSpace

U.S. FDA Expands Regulatory Approvals for LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension in Treatment of Plaque Psoriasis

Adolescents, Approvals, FDA, Pediatric exclusivity, Plaque Psoriasis, Scalp plaque psoriasis

LEO Pharma Inc announced the U.S. Food and Drug Administration 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. Additionally, the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.

August 1, 2019/by Business Wire