Coronavirus (COVID-19) Update: December 22, 2020

For Rapid Release:

The U.S. Foodstuff and Drug Administration these days declared the following steps taken in its ongoing reaction energy to the COVID-19 pandemic:

  • The Food and drug administration has posted translations of the Moderna COVID-19 Vaccine actuality sheet for recipients and caregivers, and the point sheet for healthcare vendors in languages together with: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will write-up further language translations of the simple fact sheet for recipients and caregivers to this webpage as we acquire the translations.
  • The Fda a short while ago accepted a few abbreviated new drug purposes (ANDAs):
    • On Dec. 18, one particular ANDA for etomidate injection, indicated for the induction of normal anesthesia. The most common side results of etomidate injection are venous pain on injection and skeletal muscle actions.
    • On Dec. 18, one particular ANDA for furosemide injection, indicated for the procedure of edema (fluid retention) linked with congestive heart failure, cirrhosis of the liver, and renal disease. Frequent facet effects of furosemide injection contain hypokalemia (very low potassium stage), hypotension (very low blood tension), and dizziness.
    • On Dec. 21, one particular ANDA for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to basic anesthesia, to aid tracheal intubation and to supply skeletal muscle mass relaxation through surgery or mechanical ventilation. Facet results of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.

      Etomidate injection and furosemide injection are provided in FDA’s Drug Lack Database. The Fda acknowledges the improved desire for specific products and solutions through the COVID-19 public health and fitness crisis, and we remain deeply dedicated to facilitating entry to secure and efficient clinical products to help address important requirements of the American public.

  • Testing updates:
    • As of Dec. 22, 306 assessments and sample collection equipment are licensed by the Food and drug administration underneath crisis use authorizations (EUAs). These include things like 233 molecular checks and sample collection products, 62 antibody checks, and 11 antigen assessments. There are 32 molecular authorizations that can be made use of with residence-gathered samples. There is a person molecular prescription at home take a look at, 1 antigen prescription at property examination, and one about-the-counter (OTC) at-property antigen check.

The Food and drug administration, an company in the U.S. Department of Health and fitness and Human Expert services, protects the public well being by assuring the safety, usefulness, and protection of human and veterinary medication, vaccines and other organic products for human use, and health care devices. The company also is accountable for the security and protection of our nation’s meals offer, cosmetics, nutritional nutritional supplements, items that give off electronic radiation, and for regulating tobacco products and solutions.


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