FDA Rebuffs Teva’s Citizen Petition on Generic Copaxone Filings

The FDA has declined to review a citizen petition submitted by Teva Neurosciences asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment until certain conditions are met. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. In addition, the FDA didn’t address or take action on Teva’s requests in the petition, the company says in a statement.
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