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Agency issues Emergency Use Authorization for hydroxychloroquine sulfate, along with a novel COVID-19 test.
FDA cleared the anti-malaria medication hydroxychloroquine sulfate for emergency use in hospitals to treat coronavirus disease (COVID-19).
It also authorized a new COVID-19 test, which can issue results in as little as five minutes.
FDA issued an Emergency Use Authorization (EUA) to permit the emergency use of hydroxychloroquine sulfate, which is also used to treat rheumatoid arthritis and lupus, supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg. or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible, FDA says in notice to healthcare providers.
FDA’s approval comes on the heels of a joint statement from the American Medical Association (AMA), American Pharmacists Association (APhA), and American Society of Health-System Pharmacists (ASHP) relaying their concerns regarding the inappropriate ordering, prescribing, or dispensing of treatments for COVID-19.
Stockpiling medications that are currently being considered as potential treatment for COVID-19 will deplete the resources for patients with conditions for which these drugs are approved to treat, the three groups say.
Meanwhile. Abbott Laboratories received EUA from FDA for the fastest available molecular point-of-care test to detect COVID-19. The Abbott ID Now COVID-19 test displays positive results in as little as five minutes and negative results in 13 minutes.
“What makes this test so different is where it can be used: outside the four walls of a traditional hospital such as in the physicians' office or urgent care clinics,” Abbott says in a press release.
The test is a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations.
Starting March 30, Abbott is ramping up production to deliver 50,000 ID NOW COVID-19 tests to the U.S. healthcare system.
FDA also recently issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test (Cepheid).
“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort,” says HHS Secretary Alex Azar in a press release.