Regis Technologies, Inc. received an Establishment Inspection Report (EIR) from the FDA stating that the company has passed pre-approval inspection (PAI) for the manufacture of 4-Aminopyridine, the active ingredient in Ampyra. Acorda Therapeutics received FDA approval of Ampyra on January 22, 2010, as a treatment to improve walking in patients with multiple sclerosis (MS). Ampyra is an oral, sustained-release tablet formulation of 4-aminopyridine. The FDA inspected Regis’s facility for ...