Posted by Michael Wonder on 19 Apr 2017
Egalet announces U.S. FDA acceptance of file for prior approval supplement for Oxaydo (oxycodone hydrochloride) tablets 10 mg and 15 mg dosage strengths
18 April 2017 - FDA goal date is 17 June 2017.
Egalet Corporation today announced that the submission of a prior approval supplement for Oxaydo (oxycodone hydrochloride) tablets, seeking approval of 10 mg and 15 mg dosage strengths, has been accepted for filing by the U.S. FDA.
The submission is based on a pharmacokinetic study demonstrating bioequivalence of Oxaydo to its reference drug, Roxicodone (oxycodone hydrochloride tablets) at the 15 mg dosage strength.
