FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Pennsylvania Court Rules PMRS Can’t Sue FDA Over RoxyBond Approval

Feb. 1, 2019

A Pennsylvania federal judge dismissed a lawsuit from Pharmaceutical Manufacturing Research Services against the FDA, saying the company lacks standing to sue the agency over its approval of Inspirion’s abuse-deterrent opioid RoxyBond.

Judge Gerald J. Pappert of the Eastern District of Pennsylvania ruled the company could not sue over approval of the drug because it does not manufacture a competing product.

Pappert rejected the drugmaker’s argument that the approval could lead to PMRS having a future drug application denied by the FDA because it compares unfavorably to RoxyBond. This is “the furthest thing from a ‘certainly impending’ injury,” Pappert said.

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