Phenylephrine finally gets FDA approval

Though used unapproved for decades, Paragon BioTeck, Inc., submitted a New Drug Application for Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, for pupil dilation. The FDA last week approved the application.

"This approval represents an important milestone not only for Paragon, but also within the eye care community as a whole," said Patrick Witham, president and CEO of Paragon. "Phenylephrine Hydrochloride Ophthalmic Solution has been marketed without FDA approval for decades, and during that time has been administered to millions of patients. "

Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist. Phenylephrine acts locally as a potent vasoconstrictor and mydriatic agent by constricting ophthalmic blood vessels and the radial muscle of the iris.