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FDA approves ceftaroline for two new indications

The U.S. Food and Drug Administration (FDA) has unanimously approved the use of the new cephalosporin ceftaroline (Cerexa) for the treatment of community-acquired bacterial pneumonia (CAP) and complicated skin infections. and soft tissue (OIKMT).

At the meeting which took place on 7 September, during the morning session on the 21st, the expert voted unanimously for the use of ceftaroline in the EP, and at the afternoon meeting , 18 members of the advisory committee also voted unanimously to approve the use of the drug in the DICMT. There were no abstentions and no member of the committee voted. The committee members noted that they very easily voted for the approval of ceftaroline according to these indications after the manufacturing company provided data on the efficacy and safety of the drug for CAP and DICMT.

Cefarolin, a beta-lactam antibiotic, belongs to the group of cephalosporins and is very active against aerobic and anaerobic Gram positive microorganisms, including many resistant strains, such as penicillin resistant and multidrug resistant strains S. pneumoniae and methicillin-resistant isolates S. aureus, as well as aerobic Gram-negative pathogens - pathogens for infections of the skin, soft tissue and respiratory system.

A committee member, Dr. Sheldon L. Kaplan (Baylor College of Medicine and Children's Hospital of Texas), indicated that we would like to expect studies on the use of ceftaroline in pediatrics (what the sponsoring company has promised ). He noted that ceftaroline is a very promising drug in children, and he hopes that the sponsor will be able to provide more information on the penetration of the drug into the cerebrospinal fluid, as this is particularly important in patients with pneumococcal bacteremia.