- For immediate release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response to the COVID-19 pandemic:
- On Oct. 12, the FDA approved an abridged 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). 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 (temporarily stopping 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 meet the critical needs of Americans.
- On October 15, the FDA updated the recall classification of the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kits and letter to healthcare 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. After the implementation of the software correction, the kits can continue to be used. If used before the software correction, positive results should be considered presumptive.
- Testing updates:
- As of today, 418 tests and sample collection devices have been approved by the FDA under emergency approvals (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 self-collected samples. There is one prescription molecular home test, three prescription home antigen tests, seven antigen over-the-counter (OTC) self-tests, and two OTC home molecular tests.
- The FDA has approved 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also approved 654 revisions to EUA authorizations.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.