Akorn, Inc. received approval from the U.S. Food and Drug Administration (FDA) on the company's New Drug Application (NDA) for Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%. Akorn intends to re-launch the product shortly. Akorn's Phenylephrine Hydrochloride Ophthalmic Solution, USP, is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil.

Phenylephrine is commonly used by optometrists, ophthalmologists and other physicians to dilate patients' pupils before ocular examinations. Akorn's approval represents the second NDA approval for an ophthalmic phenylephrine product following the approval of a competing NDA product in 2013 and the subsequent withdrawal of grandfathered products from the market in 2014. Following this approval, Akorn's product will compete against the one other approved NDA product.

However, Akorn's product does not require refrigeration, providing greater optometrist and physician convenience compared to the competing phenylephrine product. Akorn's Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% will be available in 2mL and 15mL fill sizes and Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% will be available as a 5mL fill size.