The Lovenox Benchmark: Copaxone "Far More Complex," Teva Argues In Anti-Generic Petition
Teva is using FDA’s rationale for approving generic Lovenox to argue against the approval of ANDAs for generic versions of its multiple sclerosis drug Copaxone (glatiramer).
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Sandoz/Momenta’s Glatopa (glatiramer) met four criteria for equivalence that ‘provide overlapping and confirmatory evidence of active ingredient sameness,’ FDA says.
Federal Circuit finds claims covering Copaxone’s latest expiring patent are invalid; Mylan says it plans to launch its generic of the MS drug in May 2014.
Fourth Time’s The Charm? Teva Cites Colloids in Latest Attempt to Convince FDA to Require Clinical Trials for Generic Copaxone
FDA has rejected three previous citizen petitions from Teva seeking to impose barriers on future generic filers for the MS drug.