Proper Name: BCG Live (Intravesical)
Manufacturer: Sanofi Pasteur Limited Lic#1726
- For intravesical use in the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
October 9, 2013 Approval Letter - TheraCys
To assign a new NDC code, to modify the container label to assign a 2d Data matrix and encode for lot number and expiry date, and to modify the carton labels and USPI with a new logo.
November 8, 2012 Approval Letter - TheraCys April 2012 Inspectional Observations (form 483)[ARCHIVED] Important Information about BCG Live (Intravesical)[ARCHIVED]