Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          Coronavirus (COVID-19) Update: December 22, 2020Press Announcements FDA News Release
  Coronavirus (COVID-19) Update: December 22, 2020

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  December 22, 2020
 

 

  The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

The FDA has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
	The FDA recently approved three abbreviated new drug applications (ANDAs):
	On Dec. 18, one ANDA for etomidate injection, indicated for the induction of general anesthesia. The most common side effects of etomidate injection are venous pain on injection and skeletal muscle movements.
		On Dec. 18, one ANDA for furosemide injection, indicated for the treatment of edema (fluid retention) associated with congestive heart failure, cirrhosis of the liver, and renal disease. Common side effects of furosemide injection include hypokalemia (low potassium level), hypotension (low blood pressure), and dizziness.
		On Dec. 21, one ANDA for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
		Etomidate injection and furosemide injection are included in FDA’s Drug Shortage Database. 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 the American public.
	Testing updates:
	As of Dec. 22, 306 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 233 molecular tests and sample collection devices, 62 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at home test, one antigen prescription at home test, and one over-the-counter (OTC) at-home antigen test.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.

  Related Information
  
  Related Information
              FAQs on Testing for SARS-CoV-2
	Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
	Coronavirus Disease 2019 (COVID-19)

###
Inquiries
  
    
        
         Media:
                 
      
                            Jane Hubbard
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      12/22/2020
               
               
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesHealth Topic(s)
			  Infectious Disease
			    			       			    			       Coronavirus   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop