 |
Biological Products Approved under Subpart E
| Under Subpart E, approval may be
based on a surrogate endpoint or on an effect on a clinical endpoint other
than survival or irreversible morbidity ("Surrogate") [21 CFR 601.41], or a
product may be approved with restrictions to assure safe use ("Restricted")
[21 CFR 601.42]. (See Table below) [21
CFR 601.41] Surrogate - Approval based on a surrogate endpoint or on
an effect on a clinical endpoint other than survival or irreversible
morbidity.
FDA may grant marketing approval for a biological
product on the basis of adequate and well-controlled clinical trials
establishing that the biological product has an effect on a surrogate
endpoint that is reasonably likely, based on epidemiologic, therapeutic,
pathophysiologic, or other evidence, to predict clinical benefits or on
the basis of an effect on a clinical endpoint other than survival or
irreversible morbidity. Approval under this section will be subject
to the requirement that the applicant study the biological product
further, to verify and describe its clinical benefit, where there is
uncertainty as to the relation of the surrogate endpoint to clinical
benefit, or of the observed clinical benefit to ultimate outcome.
Postmarketing studies would usually be studies already underway.
When required to be conducted, such studies must also be adequate and
well-controlled. The applicant shall carry out any such studies with
due diligence.
[21 CFR 601.42] Restricted - Approval with
restrictions to assure safe use.
(a) If FDA concludes that a biological
product shown to be effective can be safely used only if distribution or
use is restricted, FDA will require such postmarketing restrictions as are
needed to assure safe use of the biological product, such as:
(1) Distribution restricted to certain
facilities or physicians with special training or experience; or
(2) Distribution conditioned on the performance of specified medical
procedures.
(3) The limitations imposed will be commensurate with the specific
safety concerns presented by the biological product.
|
Biologics Applications Approved under 21 CFR 601.40-46 (Subpart E)*
|
Submission
Tracking # |
Trade Name |
Generic Name |
Receipt Date |
Approval Date |
AP Time |
Approval Basis |
Indication |
|
125084 |
Erbitux |
cetuximab |
14-Aug-03 |
12-Feb-04 |
5.95 |
S |
Treatment of EGFR-expressing,
metastatic colorectal carcinoma in patients who are refractory to
irinotecan-based chemotherapy (in combination with irinotecan); Treatment of
EGFR-expressing, metastatic colorectal carcinoma in patients who are
intolerant to irinotecan-based chemotherapy (administered as a single
agent)
|
|
103979 |
Fabrazyme |
agalsidase beta |
23-Jun-00 |
24-Apr-03 |
34.05 |
S |
Use in patients with Fabry
disease to reduce globotriaosylceramide (GL-3) deposition in capillary
endothelium of the kidney and certain other cell types
|
|
125019 |
Zevalin |
ibritumomab tiuxetan |
1-Nov-00 |
19-Feb-02 |
15.58 |
S |
Treatment of patients with
relapsed or refractory low grade, follicular, or transformed B-cell
non-Hodgkin's
lymphoma
|
|
103948 |
Campath |
alemtuzumab |
23-Dec-99 |
7-May-01 |
16.5 |
S |
Treatment of B-cell chronic
lymphocytic leukemia (B-CLL) in patients who have been treated with
alkylating agents and who have failed fludarabine therapy
|
|
103767 |
Ontak |
denileukin diftitox |
9-Dec-97 |
5-Feb-99 |
13.88 |
S |
Treatment of persistent or
recurrent cutaneous T-cell lymphoma (orphan indication)
|
|
103772 |
Remicade |
infliximab |
30-Dec-97 |
24-Aug-98 |
7.8 |
S |
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)
|
|
103471 |
Betaseron |
interferon beta-1b |
18-Jun-92 |
23-Jul-93 |
13.16 |
|
Treatment of multiple sclerosis
(Orphan designation)
|
| * These Therapeutic Biologics
Products were transferred from CBER to CDER effective 1-Oct-03.
R - Restricted - Approval with restrictions to assure
safe use as recorded in 21 CFR 601.42 (Subpart E)
S - Surrogate - Approval based on a surrogate
endpoint or on an effect on a clinical endpoint other than survival or
irreversible morbidity as recorded in 21 CFR 601.41 (Subpart E) |
Updated
quarterly through 9/30/04.
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Date created: October 25, 2004 |
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