A lawsuit was filed to force the FDA to make a decision on the petition PIMR filed earlier. The FDA's decision was to reject our petition.
In response, the PIMR amended its complaint to force the FDA to revoke its approval of Alair®. The FDA then filed motion to dismiss for lack of standing. PFMIR made counter arguments asking that in case the court favors dismissal, to give permission to PIMR to amend the complaint one more time.
The judge dismissed the first amended complaint saying that the complaint did not allege any specific injury to the plaintiff. The judge also gave PIMR permission to file a revised (amended) complaint.