Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
Abbokinase Urokinase	For adults for the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments, and for the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures	76-1021 / 076	Abbott Laboratories 200 Abbott Park Road Dept 037N, j45-2 Abbott Park, IL 60064-6133	10/10/2002
ACTIMMUNE Interferon gamma-1b	New Indication: Delaying the time to disease progression in patients with severe, malignant osteopetrosis		InterMune Pharmaceuticals, Inc. 3294 West Bayshore Road Palo Alto, CA 94303 License 1267	2/10/2000
Activase Alteplase			Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/18/1996
Activase Alteplase	Labeling Change: Addition of information regarding orolingual angioedema to the Precautions and Adverse Reactions sections, and bolding a statement in the Dosage and Administration section	103172 / 5009	Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	5/15/2002
Aldurazyme Laronidase	For patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Laronidase has been shown to improve pulmonary function and walking capacity. Laronidase has not been evaluated for effects on the central nervous system manifestations of the disorder	125058 / 0	Biomarin Pharmaceutical Inc 371 Bel Marin Keys Boulevard Suite 210 Novato, CA 94949 License 1649	4/30/2003
Amevive Alefacept	Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy	125036 / 0	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/30/2003
Aranesp Darbepoetin alfa	Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis	103951/0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	9/17/2001
Aranesp Darbepoetin alfa	New Indication: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy	103951 / 5001	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA License 1080	7/19/2002
Avastin (bevacizumab) Package Insert	First-line treatment for patients with metastatic colorectal cancer	125085/0	Genentech, Inc. 1 DNA Way MS#48 South San Francisco, CA 95080 Lincense 1048	2/26/2004
AVONEX Interferon beta-1a	Treatment of multiple sclerosis (orphan indication)		Biogen, Inc. 14 Cambridge Center Cambridge, MA 02142 License 1204	05/17/1996
Avonex Interferon beta-1a	Revised Package Insert: To include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide	103628 / 5001	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/31/2003
Avonex Interferon beta-1a	Indication for Use: To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form	103628 / 5021	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	5/28/2003
Becaplermin Concentrate	For further manufacture under a shared manufacturing arrangement with OMJ Pharmaceuticals, Inc.		Chiron Corporation 4560 Horton Street Emeryville, CA 94608 License 1106	12/16/1997
AVONEX Interferon beta-1a	Revised Package Insert: Updated information regarding serum neutralizing antibodies	103628 / 5008	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	11/12/2002
Betaseron Interferon beta-1b	Revised Package Insert: Revised the Clinical Studies section (include data from two studies conducted in patients with secondary progressive multiple sclerosis (MS)), Adverse Reactions and Warnings sections (include new safety information); and provided a Medication Guide	103471 / 1039	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	3/14/2003
Betaseron Interferon beta-1b Letter Label	Provides for the use of diluent in a prefilled syringe, instead of a vial configuration.	103471 / 5032	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	10/10/2003
Bexxar Tositumomab and Iodine I-131 Tositumomab	Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy	125011 / 0	Corixa Corp 1124 Columbia Street Suite 200 Seattle, WA 98104 License 1614	6/27/2003
BOTOX COSMETIC Botulinum Toxin Type A	New Indication: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age	103000 / 5000	Allergan, Inc 2525 Dupont Drive P.O. Box 195 Irvine, CA 92713-9534 License 1145	4/12/2002
BOTOX Botulinum Toxin Type A	New Indication: Treatment of cervical dystonia	103000/1004	Allergan, Inc. 2525 Dupont Drive P.O. Box 195 Irvine, CA 92713-9534 License 1145	12/21/2000
Campath Alemtuzumab	Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy	103948/0	Millennium and ILEX Partners, LP 75 Sidney Street Cambridge, MA 02139 License 1289	5/7/2001
Cathflo Activase Alteplase	New Indication: Restoration of function to central venous access devices (as assessed by the ability to withdraw blood)	103172 / 5003	Genentech Inc 1 DNA Way South San Francisco, CA 94080 License 1048	9/4/2001
CEA-Scan Arcitumomab	Imaging agent used in the detection of colorectal carcinoma		Immunomedics, Inc. 300 American Road Morris Plains, NJ 07950 License 1205	06/28/1996
Elitek Rasburicase	Initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid	103946 / 0	Sanofi-Synthelabo, Inc 9 Great Valley Parkway P.O. Box 3026 Malvern, PA 19355 License 1294	7/12/2002
Elspar Asparaginase	Revised Package Insert: Add Geriatric Use subsection in the Precautions section	101063 / 5012	Merck and Co, Inc Sumneytown Pike P.O. Box 4 UN-B121 West Point, PA 19486-0004 License 0002	8/1/2002
Enbrel Etanercept	Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDS)		Immunex Corporation 51 University Street Seattle, WA 98101 License 1132	11/02/1998
Enbrel Etanercept Letter		103795 / 5125	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	11/25/2003
Enbrel Etanercept Letter		103795 / 5123	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
Enbrel Etanercept Letter		103795 / 5110	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/17/2003
Enbrel Etanercept Letter		103795 / 5102	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	8/21/2003
Enbrel Etanercept Letter		103795 / 5099	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/9/2003
Enbrel Etanercept Letter	Rheumatoid arthritis indication.	103795 / 5097	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
Enbrel Etanercept Letter	Revision to Precautions and Adverse Reactions sections of the package insert to include patients with heart failure.	103795 / 5055	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
Enbrel Etanercept	Revised Package Insert: Information regarding concurrent Etanercept and Anakinra therapy	103795 / 5109	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	6/5/2003
Enbrel Etanercept	New Indication: Reducing signs and symptoms of active arthritis in patients with psoriatic arthritis	103795 / 5034	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	1/15/2002
Enbrel Etanercept	Updated Labeling: Higher frequency of adverse events associated with multiple doses	103795 / 5016	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	1/15/2002
Enbrel Etanercept	Revised Package Insert: Revise the Clinical Studies and Adverse Reactions sections to reflect three-year safety and efficacy information in rheumatoid arthritis patients	103795 / 5051	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	9/12/2002
Enbrel Etanercept	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 DMARD		Immunex Corporation 51 University Street Seattle, WA License 1132	6/6/2000
Enbrel Etanercept	Expanded Indication: Treatment of polyarticular course juvenile rheumatoid arthritis (JRA)		Immunex Corporation 51 University Street Seattle, WA 98101 License 1132	05/27/1999
Epogen Epoetin alfa	Pediatric Use		Amgen, Inc. 1840 DeHavilland Drive Thousand Oaks, CA 91320 License 1080	07/26/1999
Erbitux Cetuximab	Erbitux is a monoclonal antibody that targets a protein called the epidermal growth factor receptor (EGFR).	125084 / 0	ImClone Systems, Incorporated License 1695	2/12/2004
Fabrazyme Agalsidase beta	For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types	103979 / 0	Genzyme Corp One Kendall Square Cambridge, MA 02139-1562 License 1596	4/24/2003
Herceptin Trastuzumab	Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease		Genentech, Inc. 1 DNA Way S. San Francisco, CA 94080 License 1048	09/25/1998
Herceptin Trastuzumab Letter		103792 / 5046	Genentech, Inc 1 DNA Way South San Francisco, CA 94080 License 1048	10/16/2003
Herceptin Trastuzumab	Revise Package Insert: Include Vysis PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene amplification as a method to select patients for therapy	103792 / 5008	Genentech, Inc 1 DNA Way South San Francisco, CA 94080 License 1048	8/28/2002
Herceptin Trastuzumab	Updated labeling: Median survival	103792 / 5004	Genentech Inc 1 DNA Way South San Francisco, CA 94080 License 1048	12/11/2001
Herceptin Trastuzumab	Changes to the package insert, product container, and package to clarify the instructions for reconstitution		Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 License 1048	2/09/2000
Humira Adalimumab	For reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be used alone or in combination with Methotrexate (MTX) or other DMARDs.	125057 / 0	Abbott Laboratories 200 Abbott Park Road D-491, AP30–1E Abbott Park, IL 60064-6157 License 0043	12/31/2002
Indiclor Indium-In-111 Chloride Sterile Solution	Addition of a "Geriatric Use" subsection in the package insert	19862 / 12	Medi-Physics, Inc, dba Amersham Health 101 Carnegie Center Princeton, NJ 08540	4/24/2003
Indiclor Indium In-111 Chloride Sterile Solution	Use in radiolabeling Ibritumomab Tiuxetan (Zevalin) and remove use in radiolabeling Imciromab Pentetate (Myoscint)	19-862 / 006	Medi-Physics, Inc d.b.a. Amersham Health 101 Carnegie Center Princeton, NJ 08540	2/19/2002
Indium In-111 Chloride Sterile Solution	Use in radiolabeling Ibritumomab Tiuxetan (Zevalin) and remove use in radiolabeling Imciromab Pentetate (Myoscint)	19-841 / 003	Mallinkrodt, Inc P.O.Box 5840 675 McDonnell Boulvard St. Louis, MO 63134	2/19/2002
Infergen Interferon alfacon-1	Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum anti-bodies and/or the presence of HCV RNA		Amgen, Inc.,Amgen Center 1840 DeHavilland Dr. Thousand Oaks, CA. License 1080	10/06/1997
Infergen Interferon alfacon-1	Revised: To provide a Medication Guide	103663 / 5011	InterMune, Inc 3280 Bayshore Blvd Brisbane, CA 94005 License 1626	11/4/2002
Infergen Interferon alfacon-1	Expanded Indication: Subsequent treatment of HCV-infected patients who have tolerated an initial course of Interferon therapy with 15 ug of Interferon alfacon-1 for 48 weeks		Amgen, Inc. 1 Amgen Center Dr. Thousand Oaks, CA 91320-1789 License 1080	12/22/1999
Infergen Interferon alfacon-1	Expanded Indication: Subsequent treatment of HCV-infected patients who have tolerated an initial course of interferon therapy		Amgen, Inc. Amgen Center 1840 DeHavilland Dr. Thousand Oaks, CA 91320	10/06/1997
Interferon alfa-2a	Removal of Kaposi's sarcoma indication.	103145/5026	Hoffman-LaRoche	9/10/2003
Intron A Interferon alfa-2	New Indication: For treatment of hepatitis B in pediatric patients		Schering Corporation 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	08/18/1998
Intron A Interferon alfa-2	Expanded Indication: Extend therapy duration for chronic hepatitis C from 6 months to 18-24 months		Schering Corporation 2000 Galloping Hill Rd Kenilworth, NJ 07033 License 0994	03/26/1997
Intron A Interferon alfa-2	New Indication: Treatment of follicular lymphoma in conjunction with chemotherapy		Schering Corporation 2000 Galloping Hill Rd. Kenilworth, NY 07033 License 0994	11/06/1997
Kineret Anakinra	Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDS)	103950/0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	11/14/2001
Kineret Anakinra Letter		103950 / 5019	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	8/21/2003
Kineret Anakinra	Revised Package Insert: Include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia	103950 / 5013	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	6/27/2003
MYOBLOC Botulinum Toxin Type B	Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain	103846/0	Elan Pharmaceuticals 800 Gateway Boulevard S. San Francisco, CA 94080 License 1579	12/8/2000
Myoscint Imciromab Pentetate	Cardiac imaging agent for detection of myocardial necrosis		Centocor B.V. 2300 AG Leiden Einsteinweg 101 P.O. Box 251 NETHERLANDS License 1178	07/03/1996
Neulasta Pegfilgrastim	To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia	125031 / 0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1799 License 1080	1/31/2002
Neumega Oprelvekin	Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia		Genetics Institute, One Burtt Road Andover, MA 01810 License 1163	11/25/1997
Neumega Oprelvekin	Revised Package Insert: Update the Warnings and Precautions sections and to add important safety information	103694 / 1009	Genetics Institute, Inc Wyeth Pharmaceuticals 150 North Radnor-Chester Road License 1163	9/18/2002
Neumega Oprelvekin	Revised Package Insert: To state that a safe and effective dose has not been established for pediatric patients and to add important new safety information	103694 / 5004	Genetics Institute, Inc Wyeth Pharmaceuticals 150 North Radnor-Chester Road License 1163	9/18/2002
Neupogen Filgrastim	Revised Package Insert: Include updated information regarding adult respiratory distress syndrome and splenic rupture	103353 / 5001	Amgen, Incorporated One Amgen Center Drive Thousand Oaks, CA 91320-1799 License 1080	5/29/2002
Neupogen Filgrastim	New Indication: For use in Acute Myeloid Leukemia		Amgen, Inc. 1840 DeHavilland Dr. Thousand Oaks, CA 91320-1789 License 1080	04/02/1998
Ontak Denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor		Seragen, Inc. 97 South Street Hopkinton, MA 01748 License 1258	02/05/1999
PEGASYS Peginterferon alfa-2a	Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa	103964 / 0	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	10/16/2002
PEGASYS Peginterferon alfa-2a	Expanded Indication for Use: Combination therapy with Ribavirin, USP (Copegus), for the treatment of chronic hepatitis C virus infection	103964 / 5000	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ, 07110-1199 License 0136	12/3/2002
PEG-Intron Peginterferon alfa-2b	Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age	103949/0	Schering Corp 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	1/19/2001
PEG-Intron Peginterferon alfa-2b	Expanded Indication: Combination therapy with Ribavirin, USP (Rebetol), for treatment of chronic hepatitis C	103949 / 5002	Schering Corporation 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	8/7/2001
Proleukin Aldesleukin	New Indication: Treatment of metastatic melanoma		Chiron Corporation 4560 Horton Street Emeryville, CA 94608 License 1106	01/09/1998
ProstaScint Capromab Pendetide	Labeled with Indium 111 for imaging of prostatic carcinoma		Cytogen Corp. 600 College Road East Princeton, NJ 08540 License No. 1164	10/28/1996
Pulmozyme Dornase alfa	Expanded Indication: Pediatric use in infants 3 months to 2 years, and children 2 to 4 years old		Genentech, Inc. 460 Point San Bruno Boulevard S. San Francisco, CA 94080-4990 License 1048	02/24/1998
Raptiva EFALIZUMAB Letter		125075/0	Genentech	10/27/03
Rebif Interferon beta-1a	Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability	103780 / 0	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	3/7/2002
Rebif Interferon beta-1a	Revised Package Insert: Final pivotal study report that confirms the results of 48 week data	103780 / 5010	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	5/2/2003
Regranex Becaplermin	Treatment of diabetic ulcers		OMJ Pharmaceuticals, Inc. Carr. #2, Km. 45.6 Bo. Campo Alegre Manati, PR 00674 License 1196	12/16/1997
Remicade Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5056	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
Remicade Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5020	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
Remicade Infliximab	Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)		Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	08/24/1998
Remicade Infliximab	Indication for Use: Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn’s disease	103772 / 5032	Centocor, Inc 200 Great Valley Parkway Malvern, PA 10355-1307 License 1242	4/1/2003
Remicade Infliximab	Expanded Indication: Improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate	103772 / 5004	Centocor, Inc 200 Great Valley Parkway Malvern, PA License 1242	2/27/2002
Remicade Infliximab	Expanded Indication: Reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy	103772 / 5012	Centocor, Inc 200 Great Valley Parkway Malvern, PA License 1242	6/28/2002
Remicade Infliximab	Expanded Indication: Inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate	103772/1007	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	12/29/2000
Remicade Infliximab	New Indication: For reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to Methotrexate		Centocor, Inc. 200 Great Valley parkway Malvern, PA 19355 License 1242	11/10/1999
ReoPro Abciximab	Expanded Indication: Treatment of a broader range of patients undergoing percutaneous coronary intervention; revised dosage and patient management to reduce bleeding		Centocor B.V. Einsteinweg 101, P.O. Box 251 300 AG Leiden NETHERLANDS License 1178	11/05/1997
ReoPro Abciximab	Expanded Indication: Treatment of patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours		Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/05/1997
ReoPro Abciximab Letter		103575/5025	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
ReoPro Abciximab Letter		103575/5022	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
Retavase Reteplase	Treatment of acute myocardial infarction in adults		Boehringer Mannheim Werk Penzberg GmbH Nonnenwald 2 82377 Penzberg Federal Republic of Germany License No. 1211	10/30/1996
RITUXAN Rituximab	Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma		Genentech, Inc. 1 DNA Way S. San Fran., CA 94080 License 1048	11/26/1997
Rituxan Rituximab Letter	Revision of Adverse Reactions Section of the package insert.	103737 / 5023	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA License 1235	10/9/2003
Rituxan Rituximab	Labeling Change: Use of Rituximab as a component of the Zevalin (Ibritumomab Tiuxetan) therapeutic regimen	103737 / 5005	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA License 1235	2/19/2002
Rituximab Formulated Bulk (For Further Manufacturing Use)	For further manufacture to Rituximab under shared manufacturing arrangement with Genentech, Inc.		IDEC Pharm. Corp. 11011 Torreyana Road San Diego, CA 92121 License 1235	11/26/1997
Roferon-A Interferon alfa-2a	Revised labeling: To provide for a Medication Guide	103145 / 5010	Hoffman La-Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	3/14/2003
Roferon-A Interferon alfa-2a	Revised Package Insert: Revise the Warnings section to include related to ophthalmologic disorders	103145 / 5015	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	8/15/2002
Roferon-A Interferon alfa-2	New Dosage Regimen: An induction regimen of 6 MIU three times a week for 12 weeks followed by the standard regimen given for an additional 12 to 36 weeks		Hoffman-La-Roche, Inc. 340 Kingsland Street Building 719/4 Nutley, NJ 07110-1199 License 0136	11/17/1999
Simulect Basiliximab	For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids		Novartis Pharmaceutical Corporation 59 Route 10 East Hanover, NJ 07930-1080 License 1244	05/12/1998
Simulect Basiliximab Letter		103764 / 5040	Novartis Pharmaceutical Corp One Health Plaza East Hanover, NJ 07936-1080 License 1244	11/14/2003
Simulect Basiliximab	New Dosage: Single dose 10 mg strength	103764 / 5037	Novartis Pharmaceutical Corp One Health Plaza East Hanover, NJ 07936-1080 License 1244	1/2/2003
Simulect Basiliximab	New/Expanded Indication: Use in renal transplantation in combination with triple immunosuppressive therapy; use in pediatric renal transplantation; and use of an IV bolus injection	103764 / 5003	Novartis Pharmaceutical Corp. 59 Route 10 East Hanover, NJ 7936-1080 License 1244	3/23/2001
Synagis Palivizumab	Prophylaxis of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease		MedImmune, Inc. 35 West Watkins Mill Road Gaithersburg, MD 20878 License 1252	06/19/1998
Synagis Palivizumab	Revised Package Insert:Revise Warnings and Adverse Reactions sections to include anaphylaxis and to revise the Immunogenicity subsection	103770 / 5022	Medimmune, Incorporated 25 West Watkins Mill Road License 1252	10/23/2002
TNKase Tenecteplase	Reduction of mortality associated with acute myocardial infarction (AMI)		Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/02/2000
Verluma Nofetumomab	Imaging agent for detection of extensive stage disease in patients with biopsy-confirmed, previously untreated, small cell lung cancer		Dr. Karl Thomae GmbH Birkendorfter Strasse 65 88397 Biberach/Riss GERMANY License 1199	08/20/1996
Xigris Drotrecogin alfa (activated)	Reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II)	125029/0	Eli Lilly & Co Lilly Corporate Center Indianapolis, IN 46285 License 1611	11/21/2001
Xolair Omalizumab	For adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids	103976 / 0	Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/20/2003
Zenapax Daclizumab	Prophylaxis of acuterenal allograft rejection		Hoffman-La Roche Inc. 340 Kingsland Street Bldg. 1, 2nd Floor Nutley, NJ 07110-1199 License 0136	12/10/1997
Zenapax Daclizumab	Revised Package Insert: Includes pediatric use	103749 / 5006	Hoffman-La Roche, Inc 340 Kingsland Street, Bldg. 1, 2nd floor Nutley, NJ 07110-1199 License 0136	7/29/2002
Zevalin Ibritumomab Tiuxetan	Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma; the therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan	125019 / 0	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA 92121 License 1235	2/19/2002