FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium). Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis.

This application was granted a Qualified Infectious Disease Program[1] (QIDP) designation. This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. Additionally, as part of QIDP designation, the FDA granted this application Fast Track[2] and Priority Review[3] designations.

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.

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