EMA Publishes Clinical Data from Withdrawn Application

The European Medicines Agency for the first time published data on its clinical data website from a withdrawn application, while adding clinical study reports for two generics.

Mylan recently withdrew its application for aripiprazole, a generic version of Otsuka’s Abilify, developed to treat schizophrenia and manic episodes related to bipolar disorder.

At the time of the withdrawal, the EMA’s Committee for Medicinal Products for Human Use issued a provisional opinion that Mylan’s application could not have been approved.