FDA OKs New Ophthalmic Phenylephrine Solution for Dilation

By Megan Brooks
Medscape Medical News

The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.

The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophthalmologists, and other physicians to dilate the pupil before ocular examinations.

Akorn's phenylephrine 2.5% solution will be available in 2-mL and 15-mL fill sizes, and the 10% solution will be available as a 5-mL fill size.

Akorn's phenylephrine ophthalmic solution does not require refrigeration, "providing greater optometrist and physician convenience compared to the competing phenylephrine product," the company says in a news release.

"We are excited to bring our non-refrigerated phenylephrine product back to the market shortly," Akorn Chief Executive Officer Raj Rai said in the release.

According to the American Society of Health-System Pharmacists, phenylephrine ophthalmic solution has been in short supply.

Akorn stopped manufacturing phenylephrine ophthalmic solution in April 2014 and stopped distributing the product at the end of June 2014. Alcon discontinued phenylephrine 2.5% ophthalmic solution with the Sandoz label in April 2014 and discontinued another phenylephrine 2.5% product (Mydfrin) in 2014. Hub Pharmaceuticals discontinued phenylephrine 2.5% and 10% ophthalmic solution in 2013.

Paragon BioTeck had the only FDA-approved phenylephrine ophthalmic product on the market until Akorn's product was approved this week, according to the American Society of Health-System Pharmacists.

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