Akorn, a specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals, has received approval from the US Food and Drug Administration (FDA) on the company's New Drug Application (NDA) for phenylephrine hydrochloride ophthalmic solution, USP, 2.5 per cent and 10 per cent. Akorn intends to re-launch the product shortly.
Akorn's chief executive officer Raj Rai stated, "Phenylephrine represents our first product approval of 2015 and builds on our 14 product approvals in 2014. While IMS Health estimates ophthalmic phenylephrine sales to be approximately $8 million for the three months ending November 30, 2014, we at Akorn believe the market size is significantly larger given that most ophthalmic phenylephrine products are shipped directly to physician and optometrist offices."
"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 Rai.
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 p hydrochloride ophthalmic solution, USP 2.5 per cent will be available in 2mL and 15mL fill sizes and phenylephrine hydrochloride ophthalmic solution, USP 10 per cent will be available as a 5mL fill size.