FDA rejects reformulated opioid

Dec 12, 2018

Mallinckrodt announced this week that the FDA will not approve an abuse-deterrent version of the company’s opioid product, Roxicodone. 

The agency’s decision was in contrast to an advisory panel that voted 10-7 in favor of the drug, saying that it should be labeled as abuse deterrent in its nasal form. But the FDA reportedly said that it needs more time to review Mallinckrodt’s application.  

Roxicodone is a form of oxycodone, a commonly abused narcotic. Mallinckrodt had reformulated its Roxicodone product to make it more difficult to snort or inject the drug.  

Read the full Reuters report.

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