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Scitegrity supported drug receives FDA approval

Written by Scitegrity | Sep 29, 2018 12:36:00 PM

Scitegrity supported drug receives FDA approval

The drug to treat Lambert-Eaton myasthenic syndrome (LEMS) in adults approved. Drug Abuse Potential assessments supported by Scitegrity

 

Catalyst Pharma have announced the FDA have approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Scitegrity supported Catalyst Pharma’s NDA submission by providing Drug Abuse Potential expertise and assessments for use in the NDA submission.

LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.