Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
On April 28th, the FDA approved an abbreviated new drug application (ANDA) for 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) single dose vial, indicated as an additive in parenteral (injection) fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion (to replenish sodium in patients with unusual fluid and electrolyte needs). Side effects include edema (fluid retention) and clinical symptoms resembling those of congestive heart failure.
On April 28th, the FDA updated the EUA Authorized Serology Test Performance page on the FDA’s website.The FDA provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response.
On April 29th, the FDA approved an ANDA for Morphine Sulfate Injection USP, 30 mg/30 mL (1 mg/1 mL) Single-dose (preservative-free Patient Controlled Analgesia [PCA] vial), indicated for the management of pain severe enough to require use of an opioid analgesic by PCA and for which alternative treatments are inadequate. Side effects include respiratory depression, respiratory arrest, circulatory depression, shock, and cardiac arrest. The FDA recognizes the increased demand for certain products during the COVID-19 Coronavirus public health emergency, and we remain committed to facilitating access to medical products to help address critical needs of the American public.
On April 30th, the FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. The FDA revoked the EUA in response to Battelle’s request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31st, 2021,
Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. As a reminder, decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. Moreover, earlier this month, the FDA issued a letter to health care providers recommending transitioning from use of decontaminated disposable respirators.
As of today, 369 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.
The FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 477 revisions to EUA authorizations.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.