- For Immediate Release:
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- Today, the FDA approved an abbreviated new drug application for propofol injectable emulsion USP 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL, for Single Patient Use Only. Propofol injectable emulsion 10mg/mL is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database. Side effects of propofol emulsion injection include hypotension (low blood pressure), bradycardia (low heart rate) and apnea (temporary stopping of breathing). The agency recognizes there is increased demand for certain products, such as propofol injectable emulsion, during the novel coronavirus pandemic, and remains committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- The FDA is warning consumers and health care professionals that the FDA continues to find hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but have tested positive for methanol or 1-propanol contamination. Methanol and 1-propanol are not acceptable ingredients for hand sanitizer products and can be life-threatening when ingested. The FDA also continues to find hand sanitizers that are subpotent, meaning the product contains less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Before buying or using hand sanitizer, the FDA recommends checking this list of hand sanitizers consumers should not use.
- Testing updates:
- As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.