FDA Accepts Allergan’s NDA for Rosacea DrugBy
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) filing for Allergan’s oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.
Oxymetazoline is a sympathomimetic agonist that is selective for the Î±1A-adrenoceptor over other Î±1-adrenoceptors and non-selective for the Î±2-adrenoceptors. As such, oxymetazoline is a potent vasoconstrictor of the cutaneous microvasculature.