Hemangeol regulatory update

FDA approved an NDA from Pierre Fabre for Hemangeol propranolol to treat proliferating infantile hemangioma requiring systemic therapy. The company said Hemangeol will be available in June. Pierre Fabre submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products. Hemangeol is a pediatric formulation of propranolol, a non-selective adrenergic receptor beta ( ADRB) blocker and a generic used to treat various conditions, including hypertension, angina, tremors and migraines. ...