Akorn Inc. (AKRX) announced that it has received approval from the U.S. Food and Drug Administration on the Company's New Drug Application or NDA for Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%. Akorn noted that it 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 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.
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