Biotech Values

[sodrock]

This third Citizen Petition it seems TEVA addressed the 5 criteria that were used to approve enoxaparin. The FDA basically said each product is unique and the Agency has the capability to determine whether a product is approvable or not based on the science provided by the applicant.

"At this time, the Agency does not believe that the issues cited by you regarding Copaxone merit a referral to an advisory committee. The Agency believes that it has sufficient expertise to evaluate whether any purported generic glatiramer acetate could satisfy the sameness requirement with respect to Copaxone."