Auxilto will be supplied by German Quality Pharma to the country, but the drug will not be marketed commercially. The company applied for EUA last Dec. 20, and it was approved on Jan 24.
The FDA said German Quality Pharma will supply Auxilto only to the Department of Health or the National Task Force Against COVID-19, which are the only agencies authorized to buy the drug. "The COVID-19 drug molnupiravir shall be delivered to healthcare facilities and administered only by healthcare providers, and used only for COVID-19 according to the approved indication stated herein."
The FDA said the recommended dose is 800mg administered orally every 12 hours for five days, but cautions that it is not recommended for women with childbearing potential, as well as pregnant and lactating women.
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