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Anonymous ID: 561bd8 June 15, 2020, 9:32 a.m. No.9621617   🗄️.is đź”—kun   >>1969 >>2231

>>9621607

>https://www.marketwatch.com/story/fda-revokes-authorization-for-hydroxychloroquine-2020-06-15

https://www.fda.gov/media/138945/download

 

This letter is in response to your request, dated today, that the Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS) issued on March 28, 2020. Like BARDA’s earlier request to FDA to issue the EUA, BARDA’s request to revoke t he EUA is part of a collaborative, USG-interagency effort to rapidly respond to this continuously evolving public health emergency. Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks.