Name	Indications
Pneumococcal 7-valent conjugate vaccine (Prevnar)	Immunization of infants two, four, six and 12 to 15 months of age to prevent invasive pneumococcal disease
Antihemophilic factor (ReFacto)	Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A
BCG, live (PACIS)	Treatment of carcinoma-in-situ in the absence of associated invasive cancer of the bladder
Tenecteplase (TNKase)	Reduction of mortality associated with acute myocardial infarction
Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A and B (Murine Monoclonal), Anti A, B (MurineMonoclonal), Anti-D (Human Monoclonal) (IgM) (ID Micro Typing Systems)	First approval of monoclonal antibodies to detect ABO and D antigens in a gel test under a shared manufacturing agreement with Serologicals, LTD
Crotalidae Polyvalent Immune Fab (Ovine[CroFab])	Treatment of minimal and moderate North American Crotalidae envenomation
Botulinum Toxin Type B (MYOBLOC)	Treatment of cervical dystonia
Human Blood and Blood Components	First approval of a licensed applicant for variance from 21 CFR 640.3(d) and 21 CFR 640.3(f) for collection of blood and blood components from donors with hereditary hemochromatosis
Human Immunodeficiency Virus Type 1 and 2 (Synthetic Peptide) (Genetic Systems HIV-1/HIV-2 Peptide EIA)	Expanded indication: Testing of cadaveric serum samples
Interferon gamma-1b (Actimmune)	New indication: For delaying the time to disease progression in patients with severe, malignant osteoporosis
Autologous Cultured Chondrocytes (Carticel Service)	Revised indication: Narrowing the indication to second-line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure
Etanercept (Enbrel)	Expanded indication: Reducing the signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis, including those who have not previously failed treatment with a disease-modifying antirheumatic drug
Antihemophilic Factor (Recombinant) (Kogenate FS)	New product formulation
Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed (Tripedia)	Expanded patient population: Include a fifth dose at four to six years after four prior doses of Tripedia
Anti-D, Anti-A, Anti-B, Anti-A, B Monoclonal Antibodies	First approvals of monoclonal antibodies to detect ABO and D antigens in a gel test. For further manufacturing in a shared manufacturing agreement with MicroTyping Systems, Inc.
A/B/D Monoclonal Grouping Combination Gel Card (ID Micro Typing Systems)	First approval for production of a monoclonal grouping combination gel card
Botulinum Toxin Type A (BOTOX)	New indication: Treatment of cervical dystonia
Infliximab (Remicade)	Expanded indication: To include the inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate
Home-Access HIV-1 Test System2	HIV testing service to be used with the Organon Teknika Vironostika HIV-1 Microelisa System using the rapid elution protocol, allows test result availability within 24 hours
Roche Amplicor HIV-1 Monitor Test	Expanded indication: In vitro test for the quantitation of HIV-1 RNA in human plasma, allows monitoring patient and disease prognosis of HIV disease