Akorn announced it has received approval from the Food and Drug Administration (FDA) on its New Drug Application (NDA) for Phenylephrine HCl Ophthalmic Solution. This is the second ophthalmic phenylephrine product available following one approval in 2013 and a withdrawal of grandfathered products in 2014.
Phenylephrine HCl Ophthalmic Solution, an alpha-1 adrenergic receptor agonist, is indicated for pupil dilation prior to ocular exams. It possesses vasoconstrictor and mydriatic properties. It exhibits rapid and moderately prolonged action, and it produces little rebound vasodilation.
Phenylephrine HCl OphthalmicSolution will be available as a 2.5% strength in 2mL and 15mL fill sizes, and as a 10% in a 5mL fill size in the near future. Akorn’s formulation does not require refrigeration.
For more information call (800) 932-5676 or visit Akorn.com.