- 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 Feb. 16, the FDA approved two abbreviated new drug applications (ANDAs) for piperacillin and tazobactam for injection (ANDAs 208674 and 208675), indicated to treat intra-abdominal infections in adult and pediatric patients 2 months of age and older, nosocomial pneumonia in adult and pediatric patients 2 months of age and older, skin and skin structure infections in adults, female pelvic infections in adults and community-acquired pneumonia in adults. The most common side effects of piperacillin and tazobactam for injection are diarrhea, constipation, nausea, headache and insomnia.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Dr. Paul’s Lab for selling an unapproved product with fraudulent COVID-19 claims. The company sells “COVID-Aid Tincture,” and misleadingly represents the product can treat or prevent COVID-19 in people. The FDA requested that Dr. Paul’s Lab take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 331 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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.