Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired...(sed as an empiric monotherapy to treat a...),Health

TYGACIL, a first-in-class glycylcycline, is an IV antibiotic with an expanded broad spectrum of in vitro activity against gram positives, gram negatives, anaerobes, methicillin-resistant and -susceptible Staphylococcus aureus (MRSA and MSSA) and vancomycin-resistant enterococci (VRE); TYGACIL is unaffected by extended-spectrum beta-lactamases (ESBLs).

In addition, TYGACIL has been shown to have in vitro activity against the following organisms: Enterococcus avium, Enterococcus casseliflavus, Enterococcus faecalis (vancomycin-resistant isolates), Enterococcus faecium (vancomycin-susceptible and -resistant isolates), Enterococcus gallinarum, Listeria monocytogenes, Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates), Acinetobacter baumannii, Aeromonas hydrophila, Citrobacter koseri, Enterobacter aerogenes, and Pasteurella multocida. The clinical significance of in vitro activity is unknown.

TYGACIL provides clinicians with an expanded broad-spectrum antibiotic option that can be used at the onset of treatment when the specific bacteria present are not yet known. In addition, TYGACIL does not require dosage adjustment in patients with impaired renal function, and is conveniently dosed every 12 hours.

Important Safety Information

-- To reduce the development of drug-resistant bacteria and maintain the

effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should

be used only to treat infections proven or strongly suspected to be

caused by susceptible bacteria

-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all

antibacterial agents, including tigecycline, and may be

life-threatening

-- TY
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