Here's your US product review and approval news in brief: KemPharm Inc. has bounced back from a complete response letter for its immediate-release opioid Apadaz (benzhydrocodone and acetaminophen) with a US FDA approval, but the company unsurprisingly missed out on abuse-deterrent language in the drug's labeling.
Keeping Track: Apadaz Approved Without Abuse-Deterrent Label, FDA Denies Translarna Appeal, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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