FDA Roundup: April 7, 2023

FDA News Release

• For Immediate Release: April 07, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued a recall notice about Philips Respironics Recall Certain Reworked DreamStations CPAP, BiPAP machines for the risk they may deliver inaccurate or insufficient therapy. Certain reworked Philips DreamStations were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, this duplication may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
• On Wednesday, the FDA published “Catching Up with Califf: FDA Actions are Reducing Exposure to Contaminants in Our Most Vulnerable Populations,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In part 2 of this series on food, Dr. Califf discusses the part of the FDA’s mission to help safeguard the food supply that includes the evaluation of the use of chemicals as food ingredients and substances that come into contact with food, and monitoring the food supply for chemical contaminants. The agency takes action when we find that a particular level of a contaminant is associated with a significantly elevated risk of an adverse health effect.  
• On Wednesday, the FDA approved the first generic flumethasone animal drug, for certain diseases that cause inflammation in horses, dogs, and cats. 
• On April 14, the FDA will hold a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee to discuss supplemental new drug application efficacy supplement for Rexulti (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia. All meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Rexulti is currently approved as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults and treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
• COVID-19 testing updates: 
  • As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
  • The FDA has authorized 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1344 revisions to EUA authorizations.