- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On June 1, the FDA approved an abbreviated new drug application for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation. Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients four years of age and older. The most common side effects associated with albuterol sulfate inhalation aerosol are headache, dizziness, tachycardia (rapid heart rate), chest pain, pharyngitis (sore throat), and rhinitis (runny nose).
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19. We remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- On June 3, the FDA posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information. The update added new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples.
- The FDA reissued the Letter of Authorization for REGEN-COV (Casirivimab and Imdevimab) treatment for COVID-19 to authorize:
- A dosage change from 1200 mg of casirivimab and 1200 mg of imdevimab to 600 mg of casirivimab and 600 mg of imdevimab;
- A new coformulation presentation that contains 600 mg of casirivimab and 600 mg of imdevimab in a single vial, and
- Addition of subcutaneous (under-the-skin) injection as an alternative route of administration when intravenous (administered into a vein) infusion is not feasible and would lead to delay in treatment.
These updates are also included in the Fact Sheet for Health Care Providers, the Fact Sheet for Patients, Parents, and Caregivers, Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) and Dear Healthcare Provider Letter.
- Testing updates:
- As of today, 380 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 275 molecular tests and sample collection devices, 80 antibody and other immune response tests and 25 antigen tests. There are 52 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 antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized nine antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 525 revisions to EUA authorizations.
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.
- Veronika Pfaeffle