The US Food and Drug Administration has kept a watchful eye on industry activity and offered guidance related to the COVID-19 pandemic over the past week. The latest developments affect drug development and use, diagnostic products, and fraudulent tests and therapies.
Over the past week, the agency approved two abbreviated new drug applications (NDAs).
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment. This typically occurs either in an intensive care setting, or with sedation of non-intubated patients prior to and/or during surgical and other procedures.
The most common side effects of dexmedetomidine hydrochloride injection are hypotension, bradycardia, and dry mouth. The drug is listed in the FDA Drug Shortage Database.
The agency also approved an abbreviated NDA for succinylcholine chloride injection USP 200 mg/10 mL, indicated in addition to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of the drug include anaphylaxis, hyperkalemia, and malignant hyperthermia.
Since the onset of the COVID-19 pandemic, the FDA reports it has worked with more than 400 test developers that have already submitted, or said they will be submitting, emergency use authorization (EUA) requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 105 tests under EUAs. These include 100 molecular tests, 12 antibody tests, and one antigen test.
Revised COVID-19 information
The agency has again revised its informational document “FDA COVID-19 Response At-A-Glance Summary.” The PDF contains a rundown of facts, figures and activities the agency has taken since the pandemic began.
The document outlines the FDA’s work in blocking fraudulent COVID-19 preventatives and treatments, issuing EUAs, ramping up production of medical equipment and monitoring the healthcare supply chain. Additionally, the electronic literature shares details of collaborative agreements, test development and other activities.
Sketchy COVID-19 products
As of this week, there are no FDA-approved products to prevent or treat COVID-19. However, that has not stopped several manufacturers from selling items designed to do just that; each of these companies (a total of 56 to date) has received a warning letter from the FDA ordering cessation of such sales.
- Apollo Holding, for selling NoronaPak products including CBD and other supplements purporting to prevent and treat the virus
- North Coast Biologics, for offering its “nCoV19 spike protein vaccine” for sale in the US.