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# Egalet Files for 2 Additional Oxayda Dosage Strengths
- URL: https://www.fdaweb.com/egalet-files-for-2-additional-oxayda-dosage-strengths/
- Published: 2017-04-19T12:00:00.000Z
- Updated: 2026-09-14T22:18:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138483

Egalet Corp. has submitted a prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets that seeks to market 10 mg and 15 mg dosage strengths for use in treating moderate to severe pain. The submission is based on a pharmacokinetic study demonstrating bioequivalence of Oxaydo to its reference drug, Roxicodone (oxycodone hydrochloride) at the 15 mg dosage strength, according to the company.

Oxaydo, which was originally approved 12/2015 in 5 mg and 7.5 mg dosage strengths, is designed to discourage intranasal abuse. It uses a patent-protected formulation that contains an inactive ingredient that may cause nasal burning if manipulated and snorted.

The submission has a user fee review date of 6/17.