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Pharmaceuticals / Submissions and Approvals

FDA Approves KemPharm Painkiller After 2016 Rejection

Feb. 28, 2018

The FDA approved KemPharm’s opioid painkiller Apadaz (benzhydrocodone and acetaminophen) for short-term acute-pain management.

KemPharm resubmitted its marketing application last September following an appeal against the agency’s initial complete response letter rejecting the application in 2016, based on concerns about its potential for intranasal abuse.

The DEA has scheduled the drug as C-II, indicating high potential for abuse.

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