The USFDA has approved a nasal antihistamine azelastine hydrochloride spray for nonprescription use through a process called partial prescription to nonprescription switch. This drug is effective against perennial allergic rhinitis indicated in adults and children above six years of age. The present approval is the first-in-class switch for nasal administration of 0.15% strength azelastine hydrochloride. The drug received approval after the manufacturers demonstrated the safety and effectiveness of the drug for self-medication by patients.
However, the use of this drug for perennial allergies in children from six months to six years and seasonal allergies in children between two to six years of age remains prescription based. Azelastine can induce drowsiness and should be avoided with alcoholic drinks, sedatives, or tranquilizers as it may increase drowsiness. Source: FDA Press…
