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US FDA Investigating Auto-Injector Problems With Copaxone Generics

 
• By Derrick Gingery

Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.

The autoinjectors for Teva's, Viatris's, and Sandoz's glatiramer acetate are each slightly different, with different instructions

Auto-injector problems that have emerged with Copaxone generics illustrate yet another issue with combination product reviews and regulation at the US Food and Drug Administration.

Postmarket surveillance since generics were approved in 2015 and 2017 revealed an increasing number of problems with bent needles and injector failures, though the exact reason for the problems is unclear

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