Risk Factors Update Summary
- FDA issued updates to opioid prescribing info in April 2023, including guidance on addiction and respiratory depression.
- Label updates now address risks from concomitant use with other CNS depressants and neonatal withdrawal.
- The FDA's communication includes opioid analgesic risk evaluation and mitigation strategy updates.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1716947&owner=exclude
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