Japan, November 20, 2008 - Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori, “Astellas”) announced today that an injectable antibiotic, in-licensed from Theravance, Inc. (headquarters: South San Francisco, CA, CEO: Rick E Winningham, “Theravance”), telavancin received a favorable recommendation from the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and Drug Administration (FDA) with a vote of 21-5 on November 19, 2008 (local time).
Telavancin is a lipoglycopeptide antibiotic. Theravance had submitted a new drug application to the FDA for telavancin for the treatment of complicated skin and skin structure infections (cSSSI) in the United States.
Astellas will continue to work closely with Theravance towards FDA approval. This news has been announced by Theravance on November 19, 2008 (local time).