Wyeth Pharmaceuticals announced that it has received and approvable letter from the U.S. Food and Drug Administration for its first-in-class antibiotic drug Tygacil. Tygacil (tigecycline) is indicated for the treatment of adult patients with community-acquired pneumonia (CAP).
Prior to granting approval the the FDA has request that Wyeth submit additional analyses supporting the safety and efficacy of the drug. The FDA also required that benefit/risk analysis be submitted for any potential liver toxicity.
"We believe the data from our current clinical development program support TYGACIL as a potential therapeutic option for patients with CAP," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "Wyeth is committed to working with the FDA to resolve the outstanding issues for TYGACIL in order to gain approval."
Tygacil has been previously approved by the FDA in June 2005 for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI).
[Source: PRNewsWire]
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