Aerie Pharmaceuticals Inc. said the U.S. Food and Drug Administration issued a complete response letter to the company's contract drug product manufacturer.
The letter was regarding a new drug application submitted by the contract manufacturer for a drug to be produced at the Tampa, Fla.-based facility, where it also produces Aerie's eye drug Rhopressa.
According to the contract manufacturer, the letter refers to a current good manufacturing practice inspection at the facility.
The company reported positive phase 3 results for Rhopressa in April, and the FDA is expected to make a ruling on the drug by Feb. 28, 2018.
Aerie said the contract manufacturer has stated that they will work closely with the FDA to determine the appropriate next steps. It believes it is probable that open issues will be resolved before the FDA's ruling on Rhopressa.