Caplin Steriles Limited gets final approval for ANDA for phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10%

(Image Credit: AdobeStock/Maksymiv Iurii)

Caplin Steriles Limited announced the US Food and Drug Administration (FDA) granted final approval for the company’s Abbreviated New Drug Application (ANDA) for Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10%.

Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is intended to be a generic equivalent version of the Reference Listed Drug (RLD), Cyclomydril, from Alcon Research LLC.¹ The drug is intended to produce mydriasis.

The FDA qualifies a drug application as an ANDA for potential approval of a generic drug product. The FDA defines a generic drug as a “product that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.”

Furthermore, generic drug applications are defined as “abbreviated” because they generally do not require preclinical (animal) and clinical (human) data to establish safety and effectiveness. However, applicants must demonstrate that their drug performs in the same manner as the innovator drug. The FDA states that to be approved, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.²

References:

1. Caplin Steriles gets USFDA approval for Phenylephrine hydrochloride Ophthalmic Solution USP. Press release; May 24, 2024. Accessed May 28, 2024. https://www.caplinpoint.net/index.php/2024/05/24/caplin-steriles-gets-usfda-approval-for-phenylephrine-hydrochloride-ophthalmic-solution-usp/

2. Abbreviated New Drug Application (ANDA). US Food and Drug. https://fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda