"Globes" has learned that Teva's fourth petition to the FDA, submitted six months ago, was denied several days ago. This was a technical rejection meaning that the FDA has not necessarily said the last word on this matter.
Sources believe that Teva had expected a negative response from the FDA, as happened on the three previous occasions. After a long detailed explanation the FDA wrote, "We are denying your request without comment on the specific requirements for approval of any generic version of Copaxone."
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