FDA Approves Non-Refrigerated Phenylephrine

The U.S. Food and Drug Administration approved Akorn’s New Drug Application (NDA) for Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%, the company announced Tuesday.

The product is indicated to dilate the pupil, and is often used before an ocular examination or surgical procedure.

This approval marks the second recent NDA approval for an ophthalmic phenylephrine product. Phenylephrine Hydrochloride Ophthalmic Solution, USP, differs from the other approved product in that it does not require refrigeration.

The 2.5% solution will be available in 2-mL and 15-mL fill sizes, and the 10% solution will be available in a 5-mL fill size.

-Meredith Edwards White

Reference:

Akorn receives FDA approval for Phenylephrine HCI Ophthalmic Solution [press release]. www.investors.akorn.com. 2015 Jan 20.