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Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
Date:5/29/2008

e disorder, Hemophilia A and opioid-induced constipation.

About Community-Acquired Pneumonia

CAP is defined as pneumonia acquired outside a hospital or long-term care facility. It is an infection of the lungs that results in decreased ability to function normally. Although pneumonia is not a reportable illness, it appears that up to 5.6 million cases of community-acquired pneumonia occur annually. In addition, hospitalization rates among patients with CAP are approximately 20 percent. Symptoms of CAP include cough, fever, chills, fatigue, shortness of breath, and chest pain.

About the CAP Clinical Trials

TYGACIL was evaluated in adults for the treatment of CAP in two phase 3, multicenter, randomized, double-blind studies. The two studies (N=418, N=434) were conducted at 116 sites in 28 countries across the globe and evaluated the efficacy and safety of tigecycline compared with levofloxacin in subjects hospitalized with CAP.

Indications

TYGACIL is indicated for the treatment of adults with:

Complicated skin and skin structure infections (cSSSI) caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis.

Complicated intra-abdominal infections (cIAI) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

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SOURCE Wyeth Pharmaceuticals
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