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Therapeutic Biological Products Approvals

We are no longer updating this page. The last update of this page occurred on December 12, 2003.

For the latest approval information on therapeutic biological products regulated by CDER, please see Drugs@FDA.

 

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