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FDA approves ceftaroline fosamil for bacterial infections
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The FDA has approved ceftaroline fosamil, an injectable antibiotic in the cephalosporin class, to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus.
“These are serious and potentially life-threatening infections for which new treatment options are needed,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “[The] FDA is committed to facilitating new antibiotic drug development.”
Ceftaroline fosamil (Teflaro, Forest Laboratories) was evaluated in four phase 3 trials that included patients aged 18 years and older. There were two trials in patients with community-acquired bacterial pneumonia and two trials in patients with acute bacterial skin and skin structure infections.
In the community-acquired bacterial pneumonia trials, 1,231 patients received either ceftaroline fosamil or ceftriaxone. In both of the trials, the ceftaroline fosamil was just as effective as ceftriaxone. In the trials of patients with acute bacterial skin and skin structure infections, 1,396 patients received ceftaroline fosamil or vancomycin plus aztreonam. Both treatments were equally effective.
The most common adverse effects associated with ceftaroline fosamil included diarrhea, nausea and rash.