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FDA OKs injectable antibiotic for MRSA, other infections

Article-FDA OKs injectable antibiotic for MRSA, other infections

Rockville, Md. — The Food and Drug Administration (FDA) has approved the injectable antibiotic ceftaroline fosamil (Teflaro, Forest Laboratories) for treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin-structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA), Docguide.com reports.

The drug’s safety and effectiveness were evaluated in four phase 3 clinical trials in patients age 18 and older (two phases each for CABP and ABSSSI). In the CABP trials, the comparator antibacterial treatment was ceftriaxone (Rocephin, Roche) and in the ABSSSI trials, vancomycin (Vancocin, ViroPharma) plus aztreonam (Azactam, Bristol-Myers Squibb).

In the CABP trials, 1,231 adult patients received ceftaroline fosamil or ceftriaxone. In both trials, ceftaroline fosamil’s effectiveness was comparable to ceftriaxone’s. In the ABSSSI trials, 1,396 adult patients received ceftaroline fosamil or vancomycin plus aztreonam. In these trials, ceftaroline fosamil was comparable to vancomycin plus aztreonam.

The most commonly reported side effects in patients treated with ceftaroline fosamil were diarrhea, nausea and rash.

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