- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Oct. 12, the FDA approved an abbreviated new drug application for propofol injectable emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), single patient-use vials. This drug 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 FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of Americans.
- On Oct. 15, the FDA updated the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits recall classification notice and the Letter to Health Care Providers to clarify that the potential for false positive results is due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits. The associated recall is to correct the software. The kits can continue to be used following the implementation of the software correction. If used before the software correction, positive results should be treated as presumptive.
- Testing updates:
- As of today, 418 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 37 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 654 revisions to EUA authorizations.
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.
- Veronika Pfaeffle