US FDA grants priority to Ryan ODEX
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Last Update: 2014-03-21
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Source: Internet
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Author: User
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Source: China Council for the promotion of drugs 2014-03-21 Eastern time on the morning of March 20, 2014, Eagle pharmaceutical company (egrx) said that the U.S Food and Drug Administration (FDA) has accepted ryanodex's new drug application and granted it priority evaluation PDUFA date is July 22, 2014 Eagle submitted a new drug application for the treatment of malignant high fever to FDA in January 2014 In February 2014, FDA conditionally accepted eagle's trade name Ryan ODEX Ryan ODEX was awarded orphan drug qualification earlier, and Eagle currently has three U.S patents for the product Eagle plans to commercialize ryanodex after it is approved and reserves its exclusive right to sell in the United States Malignant hyperthermia is a state in which a genetically susceptible individual is triggered by inhalation of a certain anesthetic or muscle relaxant succinylcholine during surgery Original link: http://www.rttnews.com/2289332/fda-oks-nda-for-eagle-pharma-orphan-drug-ryanodex-for-malignant-hypertermia.aspx
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