Teva files petition with FDA regarding COPAXONE

Teva Pharmaceutical announced that the company has filed a citizen petition regarding the approvability of purported generic versions of COPAXONE. Teva submitted this CP according to the FDA’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 FDA responded by asking Teva to resubmit the information as a CP. The FDA said, “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."