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

This article was originally published in Scrip

Executive Summary

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.

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