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KemPharm completes dispute resolution process with FDA over Apadaz application; shares up 2%

Published 09/12/2017, 10:49 AM
© Reuters.  KemPharm completes dispute resolution process with FDA over Apadaz application; shares up 2%
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  • Thinly traded nano cap KemPharm (KMPH) perks up 2% on modestly higher volume after it announced that it has completed the Formal Dispute Resolution Request (FDRR) process with the FDA related to its New Drug Application (NDA) for Apadaz (benzhydrocodone and acetaminophen). The company received a CRL on June 13, 2016.
  • The agency has notified that its NDA is complete. Its action date is February 23, 2018.
  • Previously: Ad Comm backs approval of KemPharm's pain med Apadaz but not abuse-deterrent claim; shares plummet 45% premarket (May 6, 2016)


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