FDA Approves Reformulated Oxycontin

The FDA has approved Purdue Pharma's NDA for a reformulation of OxyContin (oxycodone HCl controlled-release) Tablets.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has approved Purdue Pharma’s NDA for a reformulation of OxyContin (oxycodone HCl controlled-release) Tablets. The reformulated tablet meets the FDA’s criteria for bioequivalence to the original formulation and is an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse. OxyContin is a CII controlled substance with all the risks of Schedule II opioids, in particular, that the drug has a high potential for abuse. The reformulated ta...

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