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Egalet Receives Complete Response Letter from U.S. Food and Drug Administration for Prior Approval Supplement for 10 mg and 15 mg Dosage Strengths of OXAYDO
9:06 am ET June 20, 2017 (PR Newswire) Print
Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the prior approval supplement (PAS) of OXAYDO(R) (oxycodone HCl, USP) tablets C-II in 10 mg and 15 mg dosage strengths.
The FDA has requested more information regarding the effect of food on OXAYDO 15 mg and the intranasal abuse-deterrent properties of OXAYDO 10 mg and 15 mg. Egalet will work with the FDA to determine the path forward.
OXAYDO is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic, moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO, initially approved in December 2015 in 5 mg and 7.5 mg dosage strengths, is designed to discourage intranasal abuse. Through its novel, patent protected formulation, OXAYDO contains inactive ingredients that may cause nasal burning if manipulated and snorted. There is no evidence that OXAYDO has reduced abuse liability compared to immediate-release oxycodone.
