The U.S. Food and Drug Administration today granted an emergency use authorization (EUA) to Merck’s molnupiravir for the treatment of mild to moderate coronavirus disease (COVID-19) in adults with positive results. with direct SARS-CoV-2 virus testing, and those who are at high risk of developing severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options FDA-approved is inaccessible or clinically inappropriate.
Molnupiravir is available by prescription only and must be started as soon as possible after the diagnosis of COVID-19 and within five days of the onset of symptoms.
Molnupiravir is not authorized for use in patients under 18 years of age because molnupiravir can affect bone and cartilage growth. It is not authorized for pre- or post-exposure prophylaxis to COVID-19 or initiation of treatment in hospitalized patients with COVID-19 because the benefit of treatment has not been observed in those at initiation of treatment. treatment after hospitalization due to COVID-19.
“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of an oral tablet. Molnupiravir is limited to situations where other FDA-approved COVID-19 treatments are inaccessible or clinically inappropriate and would be a useful treatment option for some patients. with COVID-19 has a high risk of hospitalization or death,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “As new variants of the virus continue to emerge, it will be important to expand the country’s COVID-19 therapeutic arsenal using emergency use authorizations, while continuing to generate more data. data on their safety and effectiveness.”
Molnupiravir is not a substitute for vaccination in those for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and get a booster shot if eligible. Learn more about FDA-approved or authorized COVID-19 vaccines.
Molnupiravir is a drug that works by introducing errors into the genetic code of the SARS-CoV-2 virus, helping to prevent the virus from replicating further. Molnupiravir is given as four 200-milligram capsules taken every 12 hours for five days, for a total of 40 tablets.
Molnupiravir must not be used for longer than five consecutive days.
On Wednesday, USA Food and Drug Administration issued emergency use authorization (EUA) for Pfizer’s Paxlovid, nirmatrelvir tablets and ritonavir tablets, packaged for oral administration, to treat mild to moderate coronavirus disease in adults and pediatric patients 12 years of age and older weighing 88 pounds with a positive COVID test result count, and those at high risk for progression to severe COVID-19, including hospitalization or death.
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https://www.tampafp.com/fda-authorizes-merck-oral-antiviral-for-treatment-of-covid-19-in-certain-adults/ FDA Approves Merck Oral Antiviral Drugs to Treat COVID-19 in Certain Adults