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BRIEF-Egalet receives complete response letter from US FDA for prior approval supplement for 10 mg and 15 mg dosage strengths of oxaydo
June 20, 2017 / 1:25 PM / 3 months ago

BRIEF-Egalet receives complete response letter from US FDA for prior approval supplement for 10 mg and 15 mg dosage strengths of oxaydo

June 20 (Reuters) - Egalet Corp

* 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

* Egalet - FDA has requested more information regarding effect of food on oxaydo 15 mg and intranasal abuse-deterrent properties of oxaydo 10 mg and 15 mg

* Says there is no evidence that oxaydo has reduced abuse liability compared to immediate-release oxycodone Source text for Eikon: Further company coverage:

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