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Friday, August 30, 2019

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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