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news.US-based specialty pharmaceutical firm Akorn has introduced Phenylephrine HCl Ophthalmic Solution, USP, 2.5% and 10% expanding its generic and branded ophthalmic portfolio.
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Earlier in January, the company secured approval from the US Food and Drug Administration (FDA) for a new drug application (NDA) for the product.
For the twelve months ended 31 January 2015, sales of Phenylephrine Ophthalmic Solution, USP, 2.5% and 10% were $24m, according to IMS Health.
Phenylephrine Hydrochloride Ophthalmic Solution, USP, is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil.
Commonly, phenylephrine is used by optometrists, ophthalmologists and other physicians to dilate patients’ pupils before ocular examinations.
The recent approval represents the second NDA approval for an ophthalmic phenylephrine product following the approval of a competing NDA product and the subsequent withdrawal of grandfathered products from the market in 2013.
The Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%, is available in 2mL and 15mL fill sizes, while Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%, is available as a 5mL fill size.