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.
EMR MATTERS – October 2024 - The challenge is that many in the behavioral health…
TOO LITTLE, TOO LATE? – Dec. 19, 2024 - Assembly Bill 56 (AB 56) proposes…
AND STOPPED DIGGING – Dec. 4, 2024 - In a new interview with The Times,…
NOT JUST IN PENCILS – Dec. 8, 2024 - Americans born before 1966 experienced “significantly…
AS SUCCESSFUL AS EVER – Dec. 3, 2024 - Family Affair actor Johnny Whitaker looked…
ALANON Plus – Dec. 7, 2024 - A high percentage of treatment failures occur due…