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ARTICLE | Clinical News

Egalet receives CRL for 10 and 15 mg doses of pain drug Oxaydo

June 23, 2017 7:39 PM UTC

Egalet Corp. (NASDAQ:EGLT) said it received a complete response letter from FDA regarding a prior approval supplement for 10 and 15 mg dose strengths of oral Oxaydo oxycodone (Aversion). FDA requested more information about the effect of food on the product and on the product’s intranasal abuse-deterrent properties, according to the company. FDA approved the 5 and 7.5 mg dose strengths of Oxaydo in 2015 to manage acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate...