admin
India,
healthysoch
New Delhi, October 24, 2020:
The U.S. Food and Drug Administration has granted approval to the antiviral drug remdesivir to be used in adult and pediatric patients, aged 12 years and above, and weighing at least 40 kg (around 88 pounds) for the treatment of COVID-19 requiring hospitalization.
Remdesivir must only be given in a hospital or in a healthcare setting which can provide acute care comparable to inpatient hospital care. With this, remdesivir has become the first treatment for COVID-19 to receive FDA approval.
However, this approval does not include the entire population that had been authorized to use this drug under an Emergency Use Authorization (EUA) which was issued on May 1, 2020. The approval came after FDA’s analysis of data from three randomized, controlled clinical trials including patients hospitalized with mild-to-severe COVID-19
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