Does FDA's Elepsia CRL Signal Broader Compliance Woes For Sun Spin-off?

Shares of Sun Pharmaceutical Industries Ltd were dented on Indian bourses after investors appeared concerned that the US FDA's decision to rescind a previous approval for its R&D arm's new drug application (NDA) for Elepsia XR (levetiracetam extended-release tablets) implied more than met the eye.

Shares of Sun Pharmaceutical Industries Ltd were dented on Indian bourses after investors appeared concerned that the US FDA's decision to rescind a previous approval for its R&D arm's new drug application (NDA) for Elepsia XR (levetiracetam extended-release tablets) implied more than met the eye.

Sun Pharma Advanced Research Company Ltd (SPARC) is the listed R&D spin-off of Sun Pharma, which has been evaluating several...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Neurological

More from Therapy Areas