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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
2017年6月20日 / 下午1点25分 / 4 个月前

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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