The FDA is anticipated to decide on 11/26/09 for Vibativ (telavancin) as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP). But both the market and myself are expecting a delay in approval from the FDA. On November 5, 2009, Theravance, Inc. (THRX) announced that the company, in collaboration with Astellas Pharma Inc. (ALPMF.PK) will launch the first stock of VIBATIV™ in the US market. The announcement follows the approval of the drug by the U.S. Food and Drug Administration (FDA) on September 11.
Theravance is a leading biopharmaceutical company, Its development programs mostly focus on respiratory diseases, bacterial infections, and gastrointestinal disorders. It entered into collaboration with Astellas in November 2005. The terms of the collaboration specify that Astellas will manufacture and sell VIBATIV while Theravance will help in marketing the drug for the first three years post approval.