Teva Pharmaceutical Industries Ltd., (TEVA) today announced that the Company has filed a citizen petition (CP) 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 (NDA) and 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.”
Its called Greening. Keep on extending your 7 year licence to infinity. They have to thank the USA for the over abundance of Lawyers and legalese that has permeated the medical world. Reformation is now impossible.!
Hilarious - a company that makes its living on generics trying to fight against competition for one of its own drugs - what it will get is a taste of its own medicine, so to speak.....a citizens petition -what's next? how bout a bunch of naked ladies standing in front of the FDA with signs saying "naked female genetalia against generic copaxone".....
TEVA makes 9million dollars a day from this product. One would expect their legal team to at least try to earn their keep.A one month delay from generic competition would pay a few salaries,bonuses,and
stock option grants to senior management-hey we all know they deserve it. Yes even when the stock price plummets these guy's will probably get a raise.