US FDA rejects Teva's second try to block generic Copaxone; Shire sues Actavis over Intuniv

The US Food and Drug Administration has rejected a second Citizen Petition from Israel-based Teva Pharmaceutical Industries seeking to block approval of generic versions of Copaxone (glatiramer acetate), for multiple sclerosis.

According to the FDA, Teva, the world's largest generics company, asserted that it is not possible for the sponsor of an Abbreviated New Drug Application 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.