US FDA Investigating Auto-Injector Problems With Copaxone Generics
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
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Viatris’ Mylan has accused Teva of creating a perfect ‘playbook’ to delay Mylan’s launch of a generic version of its Copaxone blockbuster and then strangle uptake, something Mylan was vocal about years earlier, in a suit filed in a New Jersey court.
The popular patient-focused drug development model for new drugs might not fit for generics, in part because the affected patient groups would be much larger.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.