Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates.
The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA is set to approve or reject by February of next year. Aerie reported that it doesn’t think the manufacturer’s regulatory obstacle will impact the decision deadline for Rhopressa.
Get the full story at our sister site, Drug Delivery Business News.
The post Aerie’s contract manufacturer faces regulatory hurdle appeared first on MassDevice.