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).
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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