Teva, FDA neurology, generics news
Teva filed a suit against FDA in the U.S. District Court for the District of Columbia alleging that the agency's denial "without comment" of a December Citizen's Petition regarding multiple sclerosis drug Copaxone glatiramer acetate violates the Food, Drug & Cosmetic Act (FDCA). In December, Teva submitted its sixth Citizen's Petition asking FDA to refrain from approving any ANDA for generic versions of Copaxone unless the ANDA contains information showing the generic contains the identical active ingredient as in Copaxone; non-clinical and clinical data showing the generic poses immunogenicity risks no greater than Copaxone; and data from comparative clinical trials in patients with relapsing-remitting MS (RRMS) using relevant safety and effectiveness endpoints to show bioequivalence to Copaxone.
On May 2, FDA denied the petition without comment on the approvability of any ANDA for generic Copaxone, saying "it would be premature and inappropriate to do so at this time." The agency said any decision regarding clinical trial requirements and other conditions of approval would be made on a per product basis during its review of each specific ANDA. The suit also names HHS Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg as defendants. ...