FDA rejects second Citizen Petition for Copaxone

FDA rejected a second Citizen Petition from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) seeking to block approval of generic versions of Copaxone glatiramer acetate to treat relapsing-remitting multiple sclerosis (RRMS). FDA said it would be "premature and inappropriate" to decide on the approvability of any glatiramer acetate injection ANDA before the agency has reviewed specific data in an application or provided an applicant with "appropriate procedural protections."

According to FDA, Teva asserted that it is not possible for the sponsor of an ANDA to show that a generic has the same active ingredient because neither Copaxone nor any significant subset of its polypeptides has been fully characterized, and because it is unknown which of the polypeptides are clinically active and responsible for its therapeutic effects. The agency did say that the petition will inform its assessment of what evidence would be sufficient to show that the active ingredient in a proposed generic product is the same as that in Copaxone. Last year, FDA denied a 2008 Citizen's Petition from Teva that sought to block approval of generic versions of Copaxone, a selective major histocompatibility complex (MHC) class II modulator. ...