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FDA Approves Teflaro for Bacterial Infections
Date:10/29/2010

SSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.

In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. 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, Teflaro was comparable to Vancocin plus Azactam.  

The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.  

Teflaro is marketed by New York City-based Forest Laboratories.

For more information:

FDA: Antibiotics and Antibiotic Resistance

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/AntibioticsandAntibioticResistance/default.htm

Centers for Disease Control and Prevention (CDC): Pneumonia Can Be Prevented

http://www.cdc.gov/features/pneumonia/

CDC: Definition of MRSA

http://www.cdc.gov/mrsa/definition/index.html

CDC: Get Smart: Know When Antibiotics Work

http://www.cdc.gov/getsmart/campaign-materials/online-materials.html

Media Inquiries: Erica Jef
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SOURCE U.S. Food and Drug Administration
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