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Auto-Injector Issues Get Cross-Center Investigation From US FDA

 
• By Derrick Gingery

Reports of bent needles and injector failures in auto-injectors filled with generics of multiple sclerosis drug Copaxone also raise questions about the FDA’s complex product approval process.

THE AUTOINJECTORS FILLED WITH MULTIPLE SCLEROSIS TREATMENT GLATIRAMER ACETATE FROM TEVA, VIATRIS, AND SANDOZ ARE EACH SLIGHTLY DIFFERENT, WITH DIFFERENT INSTRUCTIONS.

Problems that have emerged in auto-injectors filled with generics for multiple sclerosis treatment Copaxone (glatiramer acetate) by multiple pharmaceutical firms illustrate yet another issue with combination product reviews and regulation at the US Food and Drug Administration, an agency official said at a recent conference.

Postmarket surveillance since the 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...

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More from Policy & Regulation

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