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COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN - Health - Nairaland

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NAFDAC To Give Emergency Approval For N400bn COVID-19 Vaccines / Stephen Hahn: Chloroquine Has Not Been Approved By FDA / Coronavirus: US Approves Chloroquine As Treatment - Trump (2) (3) (4)

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COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by Nobody: 8:03am On Mar 30, 2020
The US Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine to treat patients hospitalized with Covid-19.

30th March,2020

The US Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine to treat patients hospitalized with Covid-19.
The drugs -- which are used to treat malaria and other conditions -- have been called game changers by President Donald Trump.
But thus far, there is little scientific evidence that chloroquine, or its closely-related analogue hydroxychloroquine, are effective in treating Covid-19.

https://edition.cnn.com/world/live-news/coronavirus-outbreak-03-30-20-intl-hnk/h_e3d184969ee949b7200a3361b6010bde

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Another source: Politico

FDA issues emergency authorization of anti-malaria drug for coronavirus care
The drugs have been championed by President Donald Trump for treatment despite scant evidence.


FDA
The U.S. Food and Drug Administration building. | Jacquelyn Martin/AP Photo

By DAN DIAMOND

03/29/2020 08:03 PM EDT

The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.

The agency allowed for the drugs to be "donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.


The move was supported by the White House, part of a larger Trump-backed effort to speed the use of anti-malaria drugs as a potential therapy for a virus that has no proven treatment or cure. FDA already has allowed New York state to test administering the medication to seriously ill patients, and some hospitals have added it to their treatment protocols.

"Let's see how it works," Trump said at a press briefing on Sunday, referencing New York state's efforts. "It may. It may not."

Career scientists have been skeptical of the effort, noting the lack of data on the drug’s efficacy for coronavirus care and worried that it would siphon medication away from patients who need it for other conditions, calling instead for the agency to pursue its usual clinical trials.

Three officials told POLITICO that FDA’s planned move would facilitate more access to the drug by allowing more manufacturers to produce or donate it.

https://www.politico.com/news/2020/03/29/fda-emergency-authorization-anti-malaria-drug-155095
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by Nobody: 8:03am On Mar 30, 2020
Sean Hannity reads US Vice President Mike Pence a letter from unidentified doctor detailing a drug “regimen” the doctor claims prevents coronavirus deaths

Hannity: “Hydroxychloroquine, 200 milligrams twice a day, five days. Azithromycin, 500 milligrams once a day, five days. Zinc sulfate, 220 milligrams once a day for five days ... His results, we have had zero deaths”


SEAN HANNITY (HOST): Mr. Vice President, I'm
holding up a letter. I'm going to read from it from a second, from a doctor in the New York area, and if I may read from it -- he has now worked with his -- his associates and he has a regimen.

Hydroxychloroquine, 200 milligrams twice a day, five days. Azithromycin, 500 milligrams once a day, five days. Zinc sulfate, 220 milligrams once a day for five days. This is what he has seen, him and his team have now treated approximately 350 patients in Kiryas Joel, it was an area of New York that was hit particularly hard and another 150 patients and other New York areas.

His results, we have had zero deaths, zero hospitalizations, zero intubations, zero.


https://www.mediamatters.org/sean-hannity/sean-hannity-reads-mike-pence-letter-unidentified-doctor-detailing-drug-regimen-doctor

If u open the link you can see the video of Sean Hannity with US Vice president Mike pence and the letter from the doctor.
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by Nobody: 8:04am On Mar 30, 2020
Meaning of Emergency Approval of a Drug

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by sunnyanet(m): 8:32am On Mar 30, 2020
Abeg naija only follow a doctors prescriptions
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by oluDharay(m): 8:41am On Mar 30, 2020
Let's wait and hear from the rest of the world
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by jlinkd78(m): 8:55am On Mar 30, 2020
Following
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by kuuljay(m): 9:04am On Mar 30, 2020
The long forgotten chloroquine is finally hot cake out of reach to the poor masses in Nigeria....that's how God will pick your call out of ashes very soon

1 Like

Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by RussianKGB: 9:04am On Mar 30, 2020
Cool...some good news afterall
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by aremuforlife(m): 9:07am On Mar 30, 2020
Why is this not making a news when nafdac also have it a clinical trial
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by LivingSage: 9:07am On Mar 30, 2020
Okay
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by sapientia(m): 9:08am On Mar 30, 2020
Our own dogonyaro..

Ewo
Re: COVID-19: US FDA have given Emergency Approval For Chloroquine-CNN by Sghloiutyo: 9:28am On Mar 30, 2020

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