FDA Week - 09/06/2019

FDA Defends Ruzurgi Approval, Says It Did Not Flout Firdapse Exclusivity

By Beth Wang / September 5, 2019 at 11:51 AM
FDA denies allegations in an ongoing lawsuit with drug pricing undertones that two drugs approved to treat Lambert-Eaton myasthenic syndrome (LEMS), Firdapse and Ruzurgi, are the same even though they are indicated for different populations. The agency argues that while both drugs contain the same active ingredient, LEMS in adults is not the same as LEMS in children ages 6 to 17 years old, so FDA’s approval of Ruzurgi for children does not violate Firdapse’s orphan drug exclusivity for adult...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.