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.

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

More from Biosimilars & Generics