March 22, 2013
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FDA approves phenylephrine hydrochloride solution to dilate pupil

Phenylephrine hydrochloride ophthalmic solution USP 2.5% and 10% has been approved by the U.S. Food and Drug Administration, Paragon BioTeck announced in a news release.

The solution, an alpha-1 adrenergic receptor agonist used to dilate the pupil, has been marketed for decades without FDA approval, the release said. The approval ensures it is safe and manufactured with proper oversight.

The 2.5% solution is intended for topical use in patients younger than 1 year or those with hypertension or thyrotoxicosis. The 10% solution can be used topically in all other patients, the release said.