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FDA Approves New Indication for Wyeth's TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
Date:3/24/2009

Indication Offers New Option for Adult Patients Suffering From Community-Acquired Bacterial Pneumonia

COLLEGEVILLE, Pa., March 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) approved TYGACIL(R) (tigecycline), for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible strains of indicated pathogens. TYGACIL was first approved by the FDA in 2005 for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) caused by susceptible strains of indicated pathogens in adults.

"The approval of this new indication is timely. Antibiotic resistance continues to grow and new antimicrobials are needed," says Joseph Camardo, M.D., Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "The approval of TYGACIL for CABP is an important milestone in Wyeth's commitment to exploring new treatment options in the anti-infective therapeutic area."

Thomas File, M.D., Chief of Infectious Disease Services for Summa Health System in Akron, Ohio, says, "CABP is a serious and potentially fatal respiratory disease that affects millions of Americans each year. The approval of TYGACIL for CABP means that physicians will have an additional option available to treat patients suffering from the disease."

CABP accounts for an estimated 4.5 million visits to physician offices, emergency departments, and outpatient clinics each year.

About the CABP Clinical Trials

The approval was based on results of two randomized, double-blind, active-controlled, multinational studies (Studies 308 and 313) that evaluated TYGACIL for the treatment of CABP in adults. The two studies (N=85
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SOURCE Wyeth Pharmaceuticals
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