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FDA Revokes Emergency Use Status Of Hydroxychloroquine, Hyped By Trump For Coronavirus

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FDA Revokes Emergency Use Status Of Hydroxychloroquine, Hyped By Trump For Coronavirus

The FDA revoked emergency use of the malaria drug hydroxychloroquine for COVID-19 on Monday.

What Happened: In March, President Donald Trump revealed he is taking hydroxychloroquine.

Previously the drug was approved by the FDA for the treatment of malaria and rheumatoid arthritis — and may have serious side effects.

In a letter, the FDA revoked the EUA for emergency use of HCQ and CQ to treat COVID-19, pursuant to section 564(g)(2) of the Act.

"FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” the FDA said. 

Why It's Important: Hydroxychloroquine is produced by Teva Pharmaceutical Indus (NYSE: TEVA) and Mylan (NASDAQ: MYL). The compound that was being targeted by health researchers is called hydroxychloroquine and is sold by Teva under the brand name Plaquenil.

In March, Teva said it had donated 6 million doses of hydroxychloroquine sulfate to hospitals around the U.S.

One of the difficulties facing American investors during the COVID-19 outbreak has been separating fact from fiction, rumor from truth and speculation from confirmation.

What's Next: Cases could still occur where the drug is used to treat coronavirus despite the lack of an EUA. 

Teva shares were trading up 2.12% at $11.49 at the time of publication Monday. The stock has a 52-week high of $13.76 and a 52-week low of $6.07.

Mylan shares were trading up 0.41% at $16 on Monday. The stock has a 52-week high of $23.11 and a 52-week low of $12.75.

Related Links:

Teva Reports Q4 Earnings Beat

Mylan Reports Q2 Earnings Beat

 

Related Articles (MYL + TEVA)

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Posted-In: Coronavirus Covid-19 hydroxychloroquineNews Health Care FDA General Best of Benzinga

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