Vibativ Clinical Development

Vibativ Clinical Development
Date	Action
IND Chronology (#60-237)
5/25/2002		IND submission
6/25/2002		Teleconference on safety issues, including lack of PK and safety data in females, and preclinical studies with limited animal exposures, lack of ADME data and positive findings in a non-GLP hERG assay
7/12/2004		End of Phase II meeting to discuss clinical trial protocols for both the cSSSI and hospital-acquired pneumonia indications
12/15/2005		Pre-NDA meeting at which the statistical analysis plan for superiority analysis in MRSA patients was discussed and FDA indicated the proposed safety database would be sufficient
NDA Chronology (#22-110)
12/19/2006		NDA submission
3/19/2007		Teleconference for 90-day status report; FDA notes that the only issue raised so far was the need for Theravance to justify a 10 percent non-inferiority margin
8/21/2007		Type C meeting to discuss rationale for telavancin to be designated Pregnancy Category C
10/19/2007		FDA issues "approvable" letter on PDUFA date, asking Theravance to address safety issues through more data, re-analysis or labeling, and to identify microbial isolates sensitive to telavancin and resistant to vancomycin
1/21/2008		Theravance submits response to "approvable" letter with information on vancomycin-resistant telavancin-susceptible isolates
2/25/2008		FDA cancels Feb. 27 advisory committee meeting because of potential data integrity issues and meets with sponsor to discuss the cancellation
7/24/2008		PDUFA date for second review cycle is missed because the advisory committee meeting, which is required for a new molecular entity under FDAAA, has not been held
9/15/2008		Division of Scientific Investigations submits clinical inspection summary that finds acceptable adherence to good clinical practices, resolving data integrity concerns
11/18/2008		Advisory committee recommends approval with REMS to address teratogenicity
2/20/2009		FDA issues "complete response" letter requesting a REMS to manage risks of teratogenicity and labeling to warn about teratogencicy and nephrotoxicity
3/19/2009		Theravance submits response to FDA with REMS and new labeling
9/11/2009		Approval