Teva files citizen petition with FDA regarding Copaxone complexity

Teva Pharmaceutical Industries (NYSE: TEVA) says it has filed a citizen petition (CP) regarding the approvability of purported generic versions of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Teva, the world’s largest generics company, submitted this CP according to the US Food and Drug Administration’s procedural guidance and in accordance with the agency’s desire to facilitate public review and comment regarding new scientific data on gene expression. Indeed, Teva previously submitted much of this information to its Copaxone New Drug Application and the FDA responded by asking Teva to resubmit the information as a CP. According to FDA, “This will allow others the opportunity to comment and participate in the decision-making process, will allow Teva the opportunity to comment publicly on the views and opinions of others, and will facilitate creation of an administrative record on which the Agency may base future decisions.”

CP provides new scientific data