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New Safety Measures Announced for Extended-release and Long-acting Opioids

[4-16-2014] FDA approved class-wide labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics announced on September 10, 2013, and responded to two petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).

[9/10/2013] FDA announced a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioids. These actions include proposed class-wide safety labeling changes and new postmarket requirements for all ER/LA opioid analgesics. FDA also responded to two citizen petitions.

Page Last Updated: 12/11/2014
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