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FDA Approves Remdesivir - First Drug to Treat COVID-19

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CNN   10/22/2020

Remdesivir becomes first Covid-19 treatment to receive FDA approval

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The US Food and Drug Administration approved Remdesivir for the treatment of coronavirus infection, the drug's maker, Gilead Sciences, said Thursday The drug, sold under the brand name Veklury, has been used under emergency use authorization. It is the first drug to be approved for treating Covid-19 .

"In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization," the company said in a statement.

"Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care."...

...Gilead submitted a study published in the New England Journal of Medicine that showed the drug shortened the course of illness from an average of 15 days to about 11 days in hospitalized patients....

FDA News: FDA Approves First Treatment for COVID-19

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...Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. Similar safety information about using Veklury to treat COVID-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and patients/caregivers  ...