Proper Name: BCG Live
Tradename: TICE BCG
Manufacturer: Organon Teknika Corp., LLC, License #1747
- 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
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