FDA offers updates on COVID-19 response


The US Food and Drug Administration (FDA) discussed its latest drug and testing efforts to respond to coronavirus 2019 disease.

In an update how the agency was responding to the coronavirus 2019 disease (COVID-19), the US Food and Drug Administration discussed abbreviated new drug applications, a warning letter, and an update on testing.1

The 2 drugs approved for the abbreviated new drug applications, piperacillin and tazobactam for injection, are indicated for treatment of intra-abdominal infection in pediatric patients aged 2 months and older as well as adults and nosocomial pneumonia in children aged 2 months and older and adults. The drugs also have other indications for adults including skin and skin structure infections, female pelvic infections, and community-acquired pneumonia. Diarrhea, constipation, nausea, headache, and insomnia were the most common side effects.

The agency issued a warning letter to Dr. Paul’s Lab for selling an unapproved product called COVID-Aid Tincture that had fraudulent claims. The letter requested the company take immediate action and cease the sale of the product and any other unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

The testing update indicated that there are now 331 tests and sample collection have been authorized for use by the FDA through emergency use authorizations. This includes 37 molecular authorizations that can be used with samples collected in the home. It also includes an antigen prescription at-home test, an over-the-counter at-home antigen test, and one molecular prescription at-home test.


1. US Food and Drug Administration. Coronavirus (COVID-19) Update: February 19, 2021. Published February 19, 2021. Accessed February 24, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-february-19-2021

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Tina Tan, MD, FAAP, FIDSA, FPIDS, editor in chief, Contemporary Pediatrics, professor of pediatrics, Feinberg School of Medicine, Northwestern University, pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago
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