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news.Forest Laboratories' Teflaro (ceftaroline fosamil), an injectable antibiotic, has been approved by the US Food and Drug Administration (FDA), to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
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The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI).
In the CABP trials, 1,231 adult patients received Teflaro or Rocephin, and the clinical response was based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint.
Where as, in ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam, where the clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint.
In both trials, the effectiveness of Teflaro was comparable to Rocephin.