FDA Approves Akorn's Ophthalmic Solution

The FDA has approved Akorn’s phenylephrine hydrochloride (HCl) ophthalmic solution, an alpha-1 adrenergic receptor agonist indicated to dilate the pupil.

With this latest FDA nod, the solution will return to the market following its withdrawal in 2014. The FDA had previously approved a different ophthalmic phenylephrine product in 2013, but in comparison with this competitor, Akorn’s phenylephrine HCl solution will not require refrigeration, an attribute that the manufacturer claims will grant optometrists, ophthalmologists, and other physicians greater convenience in diluting their patients’ pupils.

“We are excited to bring our non-refrigerated phenylephrine product back to the market shortly and we expect a number of additional FDA approvals and product launches as we continue to progress through 2015,” said Akorn CEO Raj Rai in a press release.

Akorn will re-launch its phenylephrine HCl ophthalmic solution in 2 strengths: 2.5%, available in 2 ml and 15 ml bottles, and 10%, available in a 5 ml bottle. The manufacturer plans to release the product soon, according to a press release.