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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Expanded Indication:
Treatment of a broader range of patients undergoing percutaneous coronary intervention; revised dosage and patient management to reduce bleeding
Expanded Indication:
Treatment of patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
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
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
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
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
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
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