NDA # |
Supp # |
Trade Name |
Generic Name |
Receipt Date |
Approval Date |
AP Time |
Approval Basis |
Indication |
21335 |
SE5 003 |
Gleevec |
imatinib mesylate |
28-Jun-02 |
20-May-03 |
10.7 |
S |
Provides for the use of Gleevec
(imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+
chronic phase CML whose disease has recurred after stem cell transplant or
who are resistant to interferon alpha therapy. There are no controlled trials
demonstrating a clinical benefit, such as improvement in disease-related
symptoms or increased survival. |
21588 |
SE5 001 |
Gleevec |
imatinib mesylate |
24-Apr-03 |
20-May-03 |
0.9 |
S |
Provides for the use of Gleevec
(imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+
chronic phase CML whose disease has recurred after stem cell transplant or
who are resistant to interferon alpha therapy. There are no controlled trials
demonstrating a clinical benefit, such as improvement in disease-related
symptoms or increased survival. |
21335 |
SE1 004 |
Gleevec |
imatinib mesylate |
28-Jun-02 |
20-Dec-02 |
5.8 |
S |
Provides for the use of Gleevec
(imatinib mesylate), 100 mg capsules for the treatment of newly diagnosed
adult patients with Philadelphia chromosome positive chronic myeloid leukemia
(CML). Follow-up is limited. |
20541 |
SE1 010 |
Arimidex |
anastrozole |
5-Mar-02 |
5-Sep-02 |
6.0 |
S |
Provides for the use of ARIMIDEX
(anastrozole) Tablets for adjuvant treatment of postmenopausal women with
hormone receptor positive early breast cancer |
21107 |
SE8 005 |
Lotronex |
alosetron hydrochloride |
7-Dec-01 |
7-Jun-02 |
6.0 |
R |
Provides for the use of Lotronex
only for women with severe diarrhea-predominant irritable bowel syndrome
(IBS) who have: chronic IBS symptoms
(generally lasting 6 months or longer), had anatomic or biochemical abnormalities
of the gastrointestinal tract excluded, and failed to respond to conventional
therapy |
21335 |
SE1 001 |
Gleevec |
imatinib mesylate |
16-Oct-01 |
1-Feb-02 |
3.6 |
S |
Provides for the use of Gleevec
(imatinib mesylate) for the treatment of patients with Kit (CD117) positive
unresectable and/or metastatic malignant gastrointestinal stromal tumors
(GIST) |
19537 |
SE1 038 |
Cipro |
ciprofloxacin hydrochloride |
1-Mar-00 |
30-Aug-00 |
6.0 |
S |
Provides for the use of CIPRO
for inhalational anthrax (post-exposure) |
19847 |
SE1 024 |
Cipro |
ciprofloxacin hydrochloride |
2-Mar-00 |
30-Aug-00 |
6.0 |
S |
Provides for the use of CIPRO
for inhalational anthrax (post-exposure) |
19857 |
SE1 027 |
Cipro |
ciprofloxacin hydrochloride |
2-Mar-00 |
30-Aug-00 |
6.0 |
S |
Provides for the use of CIPRO
for inhalational anthrax (post-exposure) |
19858 |
SE1 021 |
Cipro |
ciprofloxacin hydrochloride |
2-Mar-00 |
30-Aug-00 |
6.0 |
S |
Provides for the use of CIPRO
for inhalational anthrax (post-exposure) |
20780 |
SE1 008 |
Cipro |
ciprofloxacin hydrochloride |
2-Mar-00 |
30-Aug-00 |
6.0 |
S |
Provides for the use of CIPRO
for inhalational anthrax (post-exposure) |
21156 |
N |
Celebrex |
celecoxib |
25-Jun-99 |
23-Dec-99 |
6.0 |
S |
To reduce the number of
adenomatous colorectal polyps in Familial Adenomatous Polyposis (FAP), as an
adjunct to usual care |
50718 |
SE1 006 |
Doxil |
doxorubicin hydrochloride |
29-Dec-98 |
28-Jun-99 |
6.0 |
S |
Treatment of metastatic
carcinoma of the ovary in patients with disease that is refractory to both
paclitaxel- and platinum-based chemotherapy regimens |
20636 |
SE1 009 |
Viramune |
nevirapine |
16-Mar-98 |
11-Sep-98 |
5.9 |
S |
Provides for the inclusion of
pediatric information into the labeling |
20221 |
SE1 002 |
Ethyol |
amifostine |
9-Feb-96 |
15-Mar-96 |
1.2 |
S |
Provides for modification of
Ethyol indications, to include treatment of patients with non-small cell lung
cancer |
50697 |
N |
Biaxin |
clarithromycin |
2-Nov-92 |
23-Dec-93 |
13.7 |
S |
Provides for the treatment of
disseminated mycobacterial infections due to Mycobacterium avium and
Mycobacterium intracellular |