addiction recovery ebulletin fda declines approval
JUNE 29, 2020 – The FDA has been pushing drugmakers to develop alternatives to opioid-based painkillers as the United States grapples with opioid addiction, with prescription opioids involved in 32% of all opioid overdose deaths in 2018, according to the Centers for Disease Control and Prevention.
One of Heron’s biggest competitors for the non-opioid post-surgery painkiller is Pacira Biosciences Inc, whose long-acting Exparel is priced at $180.35 for a 10ml dose and $334.18 for the 20ml dose.
The FDA had previously declined Heron’s application, citing issues relating to manufacturing at a contract drugmaker’s site, among other things.
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