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Published 21 Mar, 2020 06:42am

Approval of drug for coronavirus still far off, says US agency

WASHINGTON: The US Food and Drug Administration (FDA) said on Friday that it has only allowed the “compassionate use” of an anti-malaria drug for treating coronavirus symptoms.

The approval for a widespread use of the drug Hydroxychloroquine was still a long way off, the FDA cautioned.

No drug can be prescribed or sold in the United States without FDA’s approval.

The agency clarified that it’s not yet aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. “The agency is investigating this issue further and will communicate publicly when more information is available,” the FDA said in a statement posted online.

In another statement, the FDA said there were “no FDA- approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective.”

On Thursday, US President Donald Trump told reporters that an anti-malaria drug has been approved for treating coronavirus symptoms and people would be trying the drug “literally within a few days”.

But Stephan Hahn, head of the FDA, told reporters he would not confirm a timeline for allowing a widespread use of this anti-malarial drug for treating Coronavirus symptoms. Since the drug was already approved for other usages and researchers had information about possible side effects, the FDA allowed its “compassionate use” quickly, he said, adding that the testing phase was now under way.

He defined the “compassionate use” as allowing doctors to do experimental use on patients and then collecting data on its safety and efficacy before a full-scale approval.

The FDA also issued a new policy on Friday that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to monitor COVID-19 patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

Published in Dawn, March 21st, 2020

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