Catalent Is Linked to Regeneron’s Eye-Drug Rejection in Latest Misstep

Problems at a Catalent Inc. production facility led US regulators to deny a key drug application from Regeneron Pharmaceuticals Inc., the latest headache for one of the main manufacturing partners to the drug industry.

The Food and Drug Administration rejected Regeneron’s application for a stronger formulation of its best-selling eye medicine Eylea “solely due to an ongoing review of inspection findings at a third-party filler,” the drugmaker said Tuesday, referring to the plant where the drug goes through the final stages of production. Catalent on Wednesday confirmed its Bloomington, Indiana, site was the facility in question, where the FDA made three observations during a pre-approval inspection.