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Proper Name: BCG Live
Tradename: TICE BCG
Manufacturer: Organon Teknika Corp., LLC, License #1747
Indications: For the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. For the prophylaxis of primary or recurrent state Ta and/or T1 papillary tumors following transurethral resection (TUR).
December 16, 2010 Approval Letter - BCG Live (TICE® BCG) and BCG Vaccine
To include revisions to the post-marketing routine stability study protocol, has been date stamped and issued.
October 8, 2009 Approval Letter[ARCHIVED]
To include a reconstitution accessory kit as a second option for reconstitution.
August 21, 1998 Approval Letter - BCG Vaccine[ARCHIVED]
To expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder.
Summary for Basis of Approval - BCG Vaccine(PDF - 1MB)
August 4, 1998
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.