|
Generic Name |
Applicant |
Submission Tracking Number |
Priority Review |
Receipt Date |
Approval Date |
Total Approval Time (Months) |
Indication/Description |
|
etanercept |
Immunex |
103795/5110 |
|
12/19/2002 |
10/17/2003 |
9.9 |
Includes a 50 mg
once weekly dosing regimen for adult rheumatoid arthritis,
psoriatic arthritis and ankylosing spondylitis patients and
juvenile rheumatoid arthritis patients. |
|
drotrecogin alfa |
Lilly |
125029/33 |
|
9/23/2002 |
10/23/2003 |
13 |
Includes
long-term survival data in the Clinical Studies section of
the package insert. |
|
basiliximab |
Novartis |
103764/5040 |
|
1/15/2001 |
11/14/2003 |
10 |
Revises the
Clinical Studies section and the Malignancies subsection of
the Adverse Reactions section of the package insert to
include five-year data. |
|
etanercept |
Immunex |
103795/5125 |
|
1/28/2003 |
11/25/2003 |
9.9 |
Revises the
Clinical Studies section of the package insert to include
four-year radiographic data for rheumatoid arthritis
patients. |
|
interferon
gamma-1b |
Intermune |
103836/5033 |
Y |
9/17/2003 |
3/18/2004 |
6 |
Revises the
Warnings, Precautions and Postmarketing Experience sections
of the package insert based on updated efficacy and safety
data for pediatric patients with chronic granulomatous
disease (CGD). |
|
interferon
beta-1a |
Serono |
103780/5027 |
|
5/29/2003 |
3/26/2004 |
9.9 |
Includes a 22
mcg dosage strength for injection three times per week. |
|
etanercept |
Immunex |
103795/5149 |
|
7/1/2003 |
4/30/2004 |
10 |
New indication
for the treatment of adult patients (18 years or older) with
chronic moderate to severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
|
|
epoetin alfa |
Amgen |
103234/5033 |
|
10/16/2002 |
5/21/2004 |
19.2 |
Updates the
Clinical Experience Cancer Patients on Chemotherapy
subsection of the package insert; revisions to the Warnings
section and revisions to the Precautions section of the
package insert to include information regarding the observed
effects of epoetin alfa and other products in this class on
response rate, time-to-progression and survival in patients
with non-myeloid tumors. |
|
epoetin alfa |
Amgen |
103234/5053 |
|
9/4/2003 |
6/30/2004 |
9.9 |
Updates the
Clinical Pharmacology, Indications and Usage, Precautions,
Adverse Reactions, and Dosage Administration sections of the
package insert to incorporate an alternative weekly dosing
regimen for the treatment of anemia due to chemotherapy in
patients with non-myeloid malignancies.
|
|
botulinum toxin
type A |
Allergan |
103000/5050 |
|
7/10/2003 |
7/19/2004 |
12.3 |
New indication
for primary axillary hyperhidrosis. |
|
adalimumab |
Abbott
|
125057/16 |
|
10/2/2003 |
7/30/2004 |
9.9 |
Expands the
indication to include improving physical function in adult
patients with moderately to severely active rheumatoid
arthritis who have had an inadequate response to one or more
DMARDS. |
|
etanercept |
Immunex |
103795/5162 |
|
11/25/2003 |
9/24/2004 |
10 |
Revises the
Clinical Studies, Adverse Reactions, and Indications and
Usage sections of the package insert (PI) and the Patient
Package Insert (PPI). |
|
etanercept |
Immunex |
103795/5184 |
|
5/28/2004 |
9/27/2004 |
4 |
New formulation
and presentation of drug product (DP): 50 mg/mL liquid
supplied in a single dose pre-filled syringe (PFS). |
|
infliximab |
Centocor |
103772/5073 |
|
12/1/2003 |
9/29/2004 |
10 |
Expands the
indication to include patients with earlier stage rheumatoid
arthritis with moderate to severe disease activity not
previously treated with methotrexate. |
| |
|
|
