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FDA misses action dates for two applications for opioid meds

  • As expected the FDA has not notified Nektar Therapeutics (NASDAQ:NKTR) about its decision with its marketing application for opioid NKTR-181 for low back pain. The agency's action date was yesterday, August 29, but it stated about a month ago that it was likely to miss the PDUFA date as it reviews its policies related to opioid painkillers.
  • The FDA has also apparently missed the August 28 action date for Intellipharmaceutics' (OTC:IPCI) refiled application for opioid oxycodone ER.
  • NKTR is down 2% premarket on light volume.

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