Actavis Seeks Label Expansion for Antibacterial Drug


Actavis recently announced that its supplemental New Drug Application to expand the label of its antibacterial drug, ceftaroline-fosamil, has been accepted for filing by the FDA.

Actavis recently announced that its supplemental New Drug Application (sNDA) to expand the label of its antibacterial drug, ceftaroline-fosamil (Teflaro), has been accepted for filing by the FDA.

The broad-spectrum bactericidal cephalosporin is currently indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by susceptible bacterial isolates of a number of microorganisms.

The FDA’s approval of the sNDA would also allow the drug to treat cases of concurrent bacteremia in patients with ABSSSIs caused by susceptible isolates of Staphylococcus aureus.

The sNDA was submitted following positive results from 2 identical trials that compared Teflaro with vancomycin plus aztreonam in ABSSSI patients. At test of cure, 90% of patients treated with Teflaro showed a comparable response to those treated with vancomycin and aztreonam, while 65% of Teflaro patients were found to have a higher response compared to vancomycin and aztreonam patients at study day 3.

“The incidence of S. aureus bacteremia and its complications has increased sharply in recent years due to the rise in frequency of invasive procedures, higher numbers of immunocompromised patients and greater resistance of S. aureus strains to available antibiotics,” said David Nicholson, senior vice president of global brands research and development for Actavis, in a press release. “We are pleased with the FDA's acceptance of this sNDA and believe a label expansion has the potential to make a meaningful difference for patients and physicians in desperate need of alternative treatment options.”

Based on guidelines set out in the Prescription Drug User Fee Act, the FDA plans to complete its review of the sNDA in the third quarter of 2015, according to an Actavis press release.

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