Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

Epinephrine_787970527_1200.jpg

The US FDA's approval of Teva Pharmaceutical Industries Ltd.'s generic version of EpiPen (epinephrine) auto-injector is a boon for the agency as well as the company. Teva overcame problems with its initial ANDA and FDA achieved part of its goal of helping to bring complex generics to market.

"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S

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 Approvals

More from Product Reviews