FDA approves phenylephrine solution

April 3, 2013

The FDA has approved a new drug application for phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% (Paragon BioTeck Inc.) to dilate the pupil.

Tigard, OR-The FDA has approved a new drug application for phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% (Paragon BioTeck Inc.) to dilate the pupil.

Phenylephrine hydrochloride is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.

“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 chief executive officer of Paragon BioTeck. “Phenylephrine hydrochloride ophthalmic solution has been marketed without FDA approval for decades, and during that time has been administered to millions of patients. With the increase in drug manufacturers domestically and abroad, FDA oversight over drug products is more important than ever. The FDA approval process is in place to ensure both that a drug is safe and that it’s manufactured under appropriate controls and oversight.”

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